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[ "Inclusion Criteria:", " Female breast cancer patient > 18 years.", " Patients must have biopsy-proven clinical Stage Ic-III invasive breast carcinoma with 10% ER expression by immunohistochemistry (IHC) analysis.", " Patients must have a pre-treatment baseline core biopsy or incisional biopsy available for additional testing (ER, protein/gene expression analysis).", " Patients must have sufficient tumor remaining following diagnostic biopsy that requires an additional definitive surgical procedure per the standard of care. Planned procedure may include lumpectomy or mastectomy as clinically indicated.", " Patients must have an ECOG Performance Status of 0 - 1.", " Patients must have the ability to understand and willingness to sign an English or a Spanish language written informed consent document.", "Exclusion Criteria:", " Male breast cancer patient.", " Patients who are pregnant or breast-feeding are excluded from the study due to potential harm to the fetus or nursing infant from the study therapy. Patients of reproductive potential must consent to use of contraception or abstinence to be eligible for the study.", " Patients may not have received prior chemotherapy or hormonal therapy for treatment of the current breast cancer.", " Patients should not have known or strongly suspected BRCA mutation by history (genetic testing not required).", " Patients will have pre-study testing, including history and physical exam, complete blood count, and measurement of renal and hepatic function. Patients will be ineligible for the study if significant abnormalities are detected, in accordance with good medical practice." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed invasive mammary carcinoma", " Stage IV disease", " Basal-like disease (triple-negative, hormone-refractory, HER2-negative)", " No locally recurrent breast cancer", " No symptomatic brain metastases", " Patients with a history of brain metastases are eligible provided they are clinically stable for > 3 weeks after completion of radiotherapy and are not taking steroids or therapeutic anticonvulsants that are cytochrome P450 3A4 (CYP3A4) modifiers", " Patients with asymptomatic brain metastases are eligible provided they are not taking prophylactic anticonvulsants that are CYP3A4 modifiers", " PATIENT CHARACTERISTICS:", " Pre- or post-menopausal", " European Cooperative Oncology Group (ECOG) performance status 0-1", " Life expectancy 6 months", " Absolute neutrophil count (ANC) 1,000/mm^3", " Platelet count 100,000/mm^3", " Creatinine 1.5 times upper limit of normal (ULN)", " Total bilirubin 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)", " Direct bilirubin will be measured in patients with Gilbert syndrome", " serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) 1.5 times ULN ( 3 times ULN in the presence of liver metastasis)", " Alkaline phosphatase 3 times ULN (in the presence of liver metastasis)", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment", " Able to swallow and retain oral medication", " No malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel", " No concurrent uncontrolled illness including, but not limited to, any of the following:", " Ongoing or active infection requiring parenteral antibiotics", " Impaired lung function (chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy)", " New York Heart Association class III-IV congestive heart failure", " Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months", " Uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg, found on 2 consecutive measurements separated by a 1-week period and despite adequate medical support)", " Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [grade 3 according to NCI Common Toxicity Criteria for Adverse Events v3.0])", " Uncontrolled diabetes (hyperosmolar state, ketoacidosis, etc.)", " Psychiatric illness or social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary", " No symptomatic neuropathy grade 2", " No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ", " No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies", " No history of hepatitis B or C", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Recovered from prior therapy", " Prior total cumulative life-time dose of doxorubicin 360 mg/m^2 or epirubicin 640 mg/m^2", " No more than 4 prior chemotherapy treatments in the metastatic setting (not including endocrine therapy or single-agent biologic therapy)", " At least 2 weeks since prior investigational drugs", " At least 14 days since prior and no concurrent herbal or dietary supplements", " At least 14 days since prior and no concurrent CYP3A4 inducers", " At least 7 days since prior and no concurrent CYP3A4 inhibitors", " Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed provided radiotherapy is initiated before study entry", " No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, biologic therapy)" ]

[ "Inclusion Criteria:", " The subject must be female and 18 years of age or older.", " The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical N0 and clinical M0 breast cancer", " The subject must have a diagnosis of primary breast cancer.", " The subject must be a candidate for surgical intervention, either with lumpectomy and SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.", " The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 - 2", " The subject must provide written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study", "Exclusion Criteria:", " The subject has clinical or radiological or pathologic evidence of metastatic cancer, including any abnormal or enlarged clinical palpable lymph nodes or core biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any lymph nodes.", " The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital blue dye was planned for use during SLNB.", " The subject has a positive pregnancy test or is lactating.", " The subject has had prior surgery to the indicated breast or axilla." ]

[ "Inclusion Criteria:", " Female 20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 10 pg/mL and FSH 30 mIU/mL within 4 weeks of randomisation.", " Hormone sensitivity (ER positive) of primary or secondary tumour tissue.", " Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.", "Exclusion Criteria:", " Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer", " Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation", " Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or" ]

[ "Adverse Events 1:", " Total: 7/113 (6.19%)", " Febrile neutropenia 1/113 (0.88%)", " Neutropenia 1/113 (0.88%)", " Anaemia 0/113 (0.00%)", " Pancytopenia 1/113 (0.88%)", " Proctitis 1/113 (0.88%)", " Device related sepsis 1/113 (0.88%)", " Gastrointestinal infection 0/113 (0.00%)", " Injection site abscess 1/113 (0.88%)", " Tooth infection 0/113 (0.00%)", " Hip fracture 0/113 (0.00%)", " Blood creatinine increased 1/113 (0.88%)", "Adverse Events 2:", " Total: 6/112 (5.36%)", " Febrile neutropenia 2/112 (1.79%)", " Neutropenia 1/112 (0.89%)", " Anaemia 1/112 (0.89%)", " Pancytopenia 0/112 (0.00%)", " Proctitis 0/112 (0.00%)", " Device related sepsis 0/112 (0.00%)", " Gastrointestinal infection 1/112 (0.89%)", " Injection site abscess 0/112 (0.00%)", " Tooth infection 1/112 (0.89%)", " Hip fracture 1/112 (0.89%)", " Blood creatinine increased 0/112 (0.00%)" ]

[ "Inclusion Criteria:", " Definitive biopsy demonstrating primary breast cancer", " Residual breast cancer requiring additional surgical resection", " Stage I, II or III disease", " Patient has ability to give signed informed consent", " Normal hepatic and renal function (creatinine<1.5, transaminases <1.5 times upper limit of normal).", " ECOG Performance status of 0 or 1.", " Age 21 years and less than 75", "Exclusion Criteria:", " Prior hormonal or surgical therapy for breast cancer", " Abnormal liver function test", " Liver or kidney problems that would interfere with metabolism of study drug", " Any condition that would hamper informed consent or ability to comply with study protocol", " Participation in another research study in the last three months", " Known malignancy at any site other than breast", " Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)", " Allergy or intolerance to any component of green tea", " Inability or refusal to comply with definitive surgical therapy" ]

[ "Inclusion Criteria:", " Female patients 18 years of age.", " Clinical/pathological documentation of residual disease after neo-adjuvant therapy.", " Patients with synchronous bilateral cancers are eligible only if:", " Index cancer is triple-negative, defined as ER-, PR-, and HER2-.", " HER2 negative tumors. HER2 negativity must be confirmed by one of the following:", " FISH-negative (FISH ratio <2.2), or", " IHC 0-1+, or", " IHC 2-3+ AND FISH-negative (FISH ratio <2.2).", " Estrogen receptor negative and progesterone receptor negative (<10% staining by IHC for estrogen receptor and progesterone receptor).", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.", " Adequate hematologic function, defined by:", " Absolute neutrophil count 2 >1000/mm3", " Platelet count 100,000/mm3", " Hemoglobin >9 g/dL", " Adequate liver function, defined by:", " AST and ALT 2.5 x the upper limit of normal (ULN)", " Total bilirubin 1.5 x ULN (unless the patient has grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin).", " Adequate renal function, defined by:", " Serum creatinine 1.5 x ULN", " Complete staging work-up 24 weeks prior to initiation of study treatment with computed tomography (CT) scans of the chest and abdomen/pelvis (abdomen/pelvis preferred; abdomen accepted), a CT scan of the head or MRI of the brain (if symptomatic), and either a positron emission tomography (PET) scan or a bone scan.", " Adequate cardiac function, defined by a left ventricular ejection fraction (LVEF) value of >50% (or normal per institutional guidelines) by MUGA scan or echocardiogram (ECHO).", " Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.", " Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.", " Patient must be accessible for treatment and follow-up.", " Women of childbearing potential must agree to use an acceptable method of birth control to avoid pregnancy for the duration of study treatment, and for 3 months thereafter.", " Able to swallow and retain oral medication.", " Patient must be willing to undergo breast biopsies as required by the study protocol.", " All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.", "Exclusion Criteria:", " Women who are pregnant or breastfeeding.", " History of previously treated ductal carcinoma in situ (DCIS) is acceptable.", " Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.", " Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);", " Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years.", " Patients who have any severe and/or uncontrolled medical conditions such as:", " unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction 6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease", " Symptomatic congestive heart failure of New York heart Association Class III or IV", " active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),", " known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),", " active, bleeding diathesis;", " Patients may not receive any other investigational or anti-cancer treatments while participating in this study.", " Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.", " Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.", " Inability to comply with study and/or follow-up procedures.", " Patients who have received live attenuated vaccines within 1 week of start of Everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines.", " Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines;", " Known history of HIV seropositivity;", " Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment. Highly effective contraception methods include combination of any two of the following (a+b or a+c or b+c):", " Use of oral, injected or implanted hormonal methods of contraception or;", " Placement of an intrauterine device (IUD) or intrauterine system (IUS);", " Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;", " Total abstinence or;", " Male/female sterilization. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential.", " Chronic treatment with corticosteroids or other immunosuppressive agents. Topical or inhaled corticosteroids are allowed;" ]

[ "Inclusion Criteria:", " breast cancer survivors over 20 years-old", " premenopausal at the time of diagnosis", " treated with operation and chemotherapy", " newly developed dyspareunia after cancer treatment", "Exclusion Criteria:", " recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)", " depression or other psychological problems", " active vaginal infection", " evidence of cancer recurrence", " previously use of lactate-containing lubricants", " other chronic diseases which severely disturb the sexual life" ]

[ "Adverse Events 1:", " Total: 17/94 (18.09%)", " Anaemia 2/94 (2.13%)", " Lymphadenopathy 0/94 (0.00%)", " Angina pectoris 0/94 (0.00%)", " Ischaemic cardiomyopathy 0/94 (0.00%)", " Myocardial infarction 1/94 (1.06%)", " Haemorrhoids 1/94 (1.06%)", " Ileus 1/94 (1.06%)", " Nausea 1/94 (1.06%)", " Vomiting 1/94 (1.06%)", " Asthenia 1/94 (1.06%)", " Disease progression 0/94 (0.00%)", " Oedema peripheral 1/94 (1.06%)", "Adverse Events 2:", " Total: 9/39 (23.08%)", " Anaemia 2/39 (5.13%)", " Lymphadenopathy 0/39 (0.00%)", " Angina pectoris 0/39 (0.00%)", " Ischaemic cardiomyopathy 0/39 (0.00%)", " Myocardial infarction 1/39 (2.56%)", " Haemorrhoids 1/39 (2.56%)", " Ileus 1/39 (2.56%)", " Nausea 1/39 (2.56%)", " Vomiting 1/39 (2.56%)", " Asthenia 1/39 (2.56%)", " Disease progression 0/39 (0.00%)", " Oedema peripheral 1/39 (2.56%)" ]

[ "Adverse Events 1:", " Total: 22/79 (27.85%)", " Anaemia 0/79 (0.00%)", " Right ventricular dysfunction 1/79 (1.27%)", " Diarrhoea 1/79 (1.27%)", " Vomiting 2/79 (2.53%)", " Abdominal pain 0/79 (0.00%)", " Colonic obstruction 0/79 (0.00%)", " Dysphagia 1/79 (1.27%)", " Nausea 1/79 (1.27%)", " Mucosal inflammation 1/79 (1.27%)", " Performance status decreased 1/79 (1.27%)", " Sudden death 1/79 (1.27%)", "Adverse Events 2:", " Total: 13/76 (17.11%)", " Anaemia 1/76 (1.32%)", " Right ventricular dysfunction 0/76 (0.00%)", " Diarrhoea 0/76 (0.00%)", " Vomiting 2/76 (2.63%)", " Abdominal pain 1/76 (1.32%)", " Colonic obstruction 1/76 (1.32%)", " Dysphagia 0/76 (0.00%)", " Nausea 1/76 (1.32%)", " Mucosal inflammation 0/76 (0.00%)", " Performance status decreased 0/76 (0.00%)", " Sudden death 0/76 (0.00%)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS)", " Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system.", " Time frame: Approximately 2 years", "Results 1: ", " Arm/Group Title: Exemestane", " Arm/Group Description: Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).", " Overall Number of Participants Analyzed: 102", " Median (95% Confidence Interval)", " Unit of Measure: Months 3.68 (1.94 to 5.26)", "Results 2: ", " Arm/Group Title: Abiraterone Acetate + Prednisone", " Arm/Group Description: Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).", " Overall Number of Participants Analyzed: 89", " Median (95% Confidence Interval)", " Unit of Measure: Months 3.65 (2.73 to 5.59)" ]

[ "Inclusion Criteria:", " Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) 50", " Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer", " Prior chemotherapy is permitted with no limit on the number of prior regimens", " Two weeks or more have elapsed since last chemotherapy or radiation treatment", " Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2", " Is female, 18 yrs of age", " Protocol defined appropriate laboratory values", " Negative pregnancy test within 7 calendar days prior to registration", " Has signed a patient informed consent", "Exclusion Criteria:", " Had prior treatment with ixabepilone or other epothilones", " Has HER2+ disease", " Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)", " Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy", " Is receiving concurrent investigational therapy or has received such therapy within the past 30 days", " Has peripheral neuropathy > Grade 1", " Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible", " Is pregnant or breast feeding" ]

[ "Inclusion Criteria:", " stage I-III breast cancer", " adjuvant or neoadjuvant anthracycline-based chemotherapy", "Exclusion Criteria:", " under age 18", " pregnancy", " metastatic or inoperable (including inflammatory) breast cancer", " confounding underlying medical illnesses", " history of mania", " history of other axis-I psychiatric disorder", " other physical or psychological impairments -" ]

[ "INTERVENTION 1: ", " Urea/Lactic Acid Cream", " Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.", "INTERVENTION 2: ", " Placebo Cream", " Patients receive placebo cream applied to palms and soles twice daily." ]

[ "Inclusion Criteria:", " Histologically and/or cytologically confirmed breast cancer", " Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen", " To have at least one measurable region", " Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1", " To have adequate organ function (bone marrow, liver and renal function)", "Exclusion Criteria:", " To have interstitial pneumonia or pulmonary fibrosis", " To have inflammatory breast cancer", " Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery", " To have brain metastases with symptoms", " To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)" ]

[ "Inclusion Criteria:", " Age: no limit", " Karnofsky performance status (KPS) 70", " No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).", " The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.", " Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.", " Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.", " Informed consent must be obtained.", " Pregnancy test must be negative for women of child bearing potential", "Exclusion Criteria:", " Inability of patient to be followed longitudinally as specified by protocol.", " Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.", " Women who are pregnant or nursing.", " Failure to meet requirements in Inclusion Criteria", " Contraindications to radiation." ]

[ "Outcome Measurement: ", " Time to Progression (TTP) - Expert Evaluation Committee Assessment", " Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).", " Time frame: Up to 2008 days of the treatment", "Results 1: ", " Arm/Group Title: Exemestane", " Arm/Group Description: One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.", " Overall Number of Participants Analyzed: 147", " Median (95% Confidence Interval)", " Unit of Measure: months 13.8 (10.8 to 16.5)", "Results 2: ", " Arm/Group Title: Anastrozole", " Arm/Group Description: One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.", " Overall Number of Participants Analyzed: 145", " Median (95% Confidence Interval)", " Unit of Measure: months 11.1 (10.8 to 16.6)" ]

[ "Outcome Measurement: ", " Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event", " This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) >=10% but <20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF >=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.", " Time frame: Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy", "Results 1: ", " Arm/Group Title: Arm I: Doxorubicin and Taxotere", " Arm/Group Description: Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.", " Overall Number of Participants Analyzed: 16", " Measure Type: Number", " Unit of Measure: participants Grade 1 After Cycle 4 (approx. 84 days): 2", " Grade 1 After Cycle 8 (approx. 168 days): 4", " Grade 1 After 30 days or more after last cycle: 1", " Grade 2 After Cycle 4 (approx 84 days): 3", " Grade 2 After Cycle 8 (approx 168 days): 4", " Grade 2 After 30 days or more after last cycle: 1", " Grade 3 After Cycle 4 (approx 84 days): 1", " Grade 3 After Cycle 8 (approx 168 days): 0", " Grade 3 After 30 days or more after last cycle: 0", "Results 2: ", " Arm/Group Title: Arm II: Doxorubicin, Taxotere, and Herceptin", " Arm/Group Description: Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.", " Overall Number of Participants Analyzed: 37", " Measure Type: Number", " Unit of Measure: participants Grade 1 After Cycle 4 (approx. 84 days): 12", " Grade 1 After Cycle 8 (approx. 168 days): 8", " Grade 1 After 30 days or more after last cycle: 10", " Grade 2 After Cycle 4 (approx 84 days): 0", " Grade 2 After Cycle 8 (approx 168 days): 2", " Grade 2 After 30 days or more after last cycle: 5", " Grade 3 After Cycle 4 (approx 84 days): 0", " Grade 3 After Cycle 8 (approx 168 days): 0", " Grade 3 After 30 days or more after last cycle: 0" ]

[ "INTERVENTION 1: ", " Nipple Reconstruction Cylinder", " Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder" ]

[ "INTERVENTION 1: ", " Arm 1: BREASTChoice (Decision Tool)", " Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.", "INTERVENTION 2: ", " Arm 2: Enhanced Usual Care (Surgical Care Booklet)", " Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet \"Breast Reconstruction.\" They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes." ]

[ "Outcome Measurement: ", " Progression-free Survival", " RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.", " Time frame: Up to 2 years", "Results 1: ", " Arm/Group Title: Dasatinib, 100 mg, Daily", " Arm/Group Description: Dasatinib, 100 mg PO daily until progression of disease", " Overall Number of Participants Analyzed: 41", " Median (95% Confidence Interval)", " Unit of Measure: weeks 10.3 (8.4 to 16.7)", "Results 2: ", " Arm/Group Title: Dasatinib, 70 mg, Twice Daily", " Arm/Group Description: Dasatinib, 70 mg PO twice daily until progression of disease", " Overall Number of Participants Analyzed: 38", " Median (95% Confidence Interval)", " Unit of Measure: weeks 15.3 (8.7 to 20.1)" ]

[ "Inclusion Criteria:", " Histologically confirmed breast cancer with accompanying pathology report;", " Submit unstained representative tumor specimen, either as a paraffin block (preferred) or 10 unstained slides", " Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);", " Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;", " Estimated life expectancy of at least 3 months", "Exclusion Criteria:", " Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;", " Pregnant or lactating;", " Known or suspected brain metastasis or leptomeningeal disease;", " History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;", " For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor." ]

[ "Outcome Measurement: ", " Number of Participants With Stomatitis Grade 2", " The incidence of grade 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.", " Time frame: 56 days", "Results 1: ", " Arm/Group Title: Dexamethasone Based Mouthwash", " Arm/Group Description: Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.", " Overall Number of Participants Analyzed: 86", " Measure Type: Number", " Unit of Measure: Participants Stomatitis grade >=2: Yes: 2", " Stomatitis grade >=2: No: 83", " Stomatitis grade >=2: Not evaluable: 1" ]

[ "Adverse Events 1:", " Total: 6", " Atrial fibrillation 1/67 (1.49%)", " Ventricular fibrillation 1/67 (1.49%)", " Gastrointestinal perforation 1/67 (1.49%)", " Periproctitis 1/67 (1.49%)", " General physical health deterioration 1/67 (1.49%)", " Escherichia sepsis 1/67 (1.49%)", " Pneumonia 1/67 (1.49%)", " Tumour pain 1/67 (1.49%)", " Renal failure acute 1/67 (1.49%)", " Pleurisy 1/67 (1.49%)" ]

[ "Adverse Events 1:", " Total: 5/32 (15.63%)", " Leukopenia 1/32 (3.13%)", " Neutropenia 1/32 (3.13%)", " Cataract 1/32 (3.13%)", " Infection 1/32 (3.13%)", " Upper respiratory tract infection 1/32 (3.13%)", " Completed suicide 1/32 (3.13%)" ]

[ "Outcome Measurement: ", " Proportion of Participants With a Pathologic Complete Response Rate", " To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.", " Time frame: 20 weeks", "Results 1: ", " Arm/Group Title: Chemo Plus Pertuzumab,Trastuzumab", " Arm/Group Description: During weeks 1-12, patients will receive pertuzumab, trastuzumab, and paclitaxel at the same time; during weeks 13-24 patients will receive pertuzumab and trastuzumab at the same time with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC).", " Pertuzumab: First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)", " Trastuzumab: For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).", " For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total).", " Paclitaxel: Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).", " 5-fluorouracil: Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).", " Epirubicin: Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).", " Cyclophosphamide: Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).", " Overall Number of Participants Analyzed: 48", " Measure Type: Number", " Unit of Measure: proportion of participants HR Positive: 23 participants", " .26 (.13 to .46)", " HR Negative: 25 participants", " .80 (.60 to .91)" ]

[ "Outcome Measurement: ", " Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population", " CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.", " Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)", "Results 1: ", " Arm/Group Title: Dasatinib Plus Letrozole", " Arm/Group Description: Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years", " Dasatinib 100 mg + Letrozole 2.5 mg", " Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days", " Overall Number of Participants Analyzed: 56", " Measure Type: Number", " Unit of Measure: participants CBR (CR+PR+SD): 40", " CBR, DFI <= 2 Years: 20", "CBR, DFI > 2 Years: 20", "Results 2: ", " Arm/Group Title: Letrozole", " Arm/Group Description: Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years", " Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days", " Overall Number of Participants Analyzed: 61", " Measure Type: Number", " Unit of Measure: participants CBR (CR+PR+SD): 40", " CBR, DFI <= 2 Years: 20", "CBR, DFI > 2 Years: 20" ]

[ "Inclusion Criteria:", " Ability to understand and the willingness to sign a written informed consent document.", " Signed written informed consent.", " Women undergoing sentinel lymph node biopsy.", " Women with breast cancer with known or suspected lymph node involvement.", " Women undergoing sentinel node identification and completion axillary lymph node dissection.", " Women of 18 years of age or older.", " Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.", " Complete Blood Count (CBC) and basic Metabolic Panel within 6 months", "Exclusion Criteria:", " History of liver or kidney failure will not be eligible.", " Allergies to iodine containing products will not be eligible.", " Women who are pregnant will not be eligible.", " Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements." ]

[ "Inclusion Criteria:", " The participant is Japanese", " The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1", " The participant has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with curative intent", " The participant has measurable and/or non-measurable disease", " The participants' primary and/or metastatic tumor is Human Epidermal Growth Factor Receptor 2 (HER2) negative", " The participant received neo adjuvant or adjuvant taxane therapy 6 months prior to the study", " The participant received neo adjuvant or adjuvant biologic therapy 6 weeks prior to the study", " The participant completed all prior radiotherapy 3 weeks prior to the study registration date", " The participant received prior hormonal therapy for breast cancer in the neo adjuvant, adjuvant,and/or the metastatic setting 2 weeks prior to the study registration date", " The participant's left ventricular ejection fraction (LVEF) is within normal ranges", " The participant has adequate hematologic, hepatic, and coagulation function.", " Eligible participants of reproductive potential agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication", "Exclusion Criteria:", " The participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. Participants with previous treatment of malignancy is eligible, provided that she has been disease free for >3 years", " The participant has a known sensitivity to docetaxel", " The participant has a known sensitivity to agents of similar biologic composition as ramucirumab", " The participant has a history of chronic diarrheal disease within 6 months prior to the study registration date", " The participant has received irradiation to a major bone marrow area within 30 days prior to the study registration date", " The participant has received any experimental agents within 4 weeks prior to the study registration date", " The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders", " The participant has Grade 3-4 bleeding within 3 months prior to the study registration date", " The participant has an ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy", " The participant has uncontrolled hypertension, symptomatic congestive heart failure, psychiatric illness, or any other serious uncontrolled medical disorders", " The participant has brain metastases", " The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness", " The participant is pregnant or lactating", " The participant has not fully recovered from effects of prior chemotherapy", " The participant has undergone major surgery within 28 days prior to the study registration date" ]

[ "Adverse Events 1:", " Total: 22/96 (22.92%)", " Anemia 1/96 (1.04%)", " lymphopenia 1/96 (1.04%)", " cardiac ischemia/infarction 1/96 (1.04%)", " sinus tachycardia 2/96 (2.08%)", " Dehydration 5/96 (5.21%)", " colitis 1/96 (1.04%)", " diarrhea 5/96 (5.21%)", " ileus 1/96 (1.04%)", " nausea 2/96 (2.08%)", " vomiting 1/96 (1.04%)", " distal small bowel obstruction 1/96 (1.04%)", " edema 1/96 (1.04%)", " fatigue 2/96 (2.08%)", "Adverse Events 2:", " Total: 6/49 (12.24%)", " Anemia 0/49 (0.00%)", " lymphopenia 0/49 (0.00%)", " cardiac ischemia/infarction 0/49 (0.00%)", " sinus tachycardia 0/49 (0.00%)", " Dehydration 1/49 (2.04%)", " colitis 0/49 (0.00%)", " diarrhea 0/49 (0.00%)", " ileus 0/49 (0.00%)", " nausea 1/49 (2.04%)", " vomiting 1/49 (2.04%)", " distal small bowel obstruction 0/49 (0.00%)", " edema 0/49 (0.00%)", " fatigue 0/49 (0.00%)" ]

[ "INTERVENTION 1: ", " Moderated Group", " one 12-week online support group led by a professional healthcare provider", "INTERVENTION 2: ", " Non-facilitated (Peer-led)", " 12-week online support in a peer-led format" ]

[ "INTERVENTION 1: ", " Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue", " One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes" ]

[ "Adverse Events 1:", " Total: 66/1748 (3.78%)", " Febrile neutropenia 2/1748 (0.11%)", " Cardiac disorders - Other, specify 3/1748 (0.17%)", " Conduction disorder 0/1748 (0.00%)", " Myocardial infarction 0/1748 (0.00%)", " Ventricular arrhythmia 1/1748 (0.06%)", " Left ventricular systolic dysfunction 0/1748 (0.00%)", " Colitis 1/1748 (0.06%)", " Diarrhea 0/1748 (0.00%)", " Duodenal ulcer 0/1748 (0.00%)", "Adverse Events 2:", " Total: 43/1748 (2.46%)", " Febrile neutropenia 1/1748 (0.06%)", " Cardiac disorders - Other, specify 1/1748 (0.06%)", " Conduction disorder 0/1748 (0.00%)", " Myocardial infarction 1/1748 (0.06%)", " Ventricular arrhythmia 0/1748 (0.00%)", " Left ventricular systolic dysfunction 1/1748 (0.06%)", " Colitis 1/1748 (0.06%)", " Diarrhea 1/1748 (0.06%)", " Duodenal ulcer 1/1748 (0.06%)" ]

[ "INTERVENTION 1: ", " Topical Saline", " Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule", " Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness", "INTERVENTION 2: ", " Topical Liquid Lidocaine", " Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule", " Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness" ]

[ "INTERVENTION 1: ", " Phase 1b (Schedule 1): Eribulin Mesilate (1.2 mg/m^2)", " Participants received eribulin mesilate 1.2 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1).", "INTERVENTION 2: ", " Phase 1b (Schedule 1): Eribulin Mesilate (1.6 mg/m^2)", " Participants received eribulin mesilate 1.6 mg/m^2, injection, intravenously, once, on Day 1 and capecitabine 1000 mg/m^2, tablets, orally, twice daily from Day 1 to 14 in each 21-day treatment cycle for as long as the treatment was clinically appropriate according to the judgment of the investigator or until the occurrence of PD, undue toxicity, the presence of other medical conditions that prohibit continuation of therapy, pregnancy, a delay of more than 14 days in starting the next cycle during Phase 1b (Schedule 1)." ]

[ "Adverse Events 1:", " Total: 29/30 (96.67%)", " Febrile neutropenia [1]3/30 (10.00%)", " Lymphatics 1/30 (3.33%)", " Diarrhea (without colostomy) 5/30 (16.67%)", " Abdominal pain or cramping 2/30 (6.67%)", " Colitis 1/30 (3.33%)", " Dehydration 1/30 (3.33%)", " Nausea 1/30 (3.33%)", " Stomatitis/pharyngitis (oral/pharyngeal/mucositis) 1/30 (3.33%)", " Vomiting 1/30 (3.33%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 61/202 (30.20%)", " FEBRILE NEUTROPENIA 1/202 (0.50%)", " LEUKOPENIA 0/202 (0.00%)", " NEUTROPENIA 2/202 (0.99%)", " CARDIAC FAILURE CONGESTIVE 0/202 (0.00%)", " CARDIO-RESPIRATORY ARREST 1/202 (0.50%)", " PERICARDIAL EFFUSION 1/202 (0.50%)", " CATARACT 1/202 (0.50%)", " OPTIC NEUROPATHY 0/202 (0.00%)", " ABDOMINAL PAIN 0/202 (0.00%)", " CONSTIPATION 0/202 (0.00%)", " DIARRHOEA 5/202 (2.48%)", "Adverse Events 2:", " Total: 42/201 (20.90%)", " FEBRILE NEUTROPENIA 0/201 (0.00%)", " LEUKOPENIA 1/201 (0.50%)", " NEUTROPENIA 0/201 (0.00%)", " CARDIAC FAILURE CONGESTIVE 1/201 (0.50%)", " CARDIO-RESPIRATORY ARREST 0/201 (0.00%)", " PERICARDIAL EFFUSION 0/201 (0.00%)", " CATARACT 1/201 (0.50%)", " OPTIC NEUROPATHY 1/201 (0.50%)", " ABDOMINAL PAIN 1/201 (0.50%)", " CONSTIPATION 1/201 (0.50%)", " DIARRHOEA 3/201 (1.49%)" ]

[ "Outcome Measurement: ", " Incidence of Treatment-emergent AE's", " [Not Specified]", " Time frame: 2 years", "Results 1: ", " Arm/Group Title: MM-111 + Herceptin", " Arm/Group Description: MM-111 will be combined with Herceptin", " MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV", " Overall Number of Participants Analyzed: 16", " Measure Type: Number", " Unit of Measure: participants 16" ]

[ "Adverse Events 1:", " Total: 9/2788 (0.32%)", " Anaphylaxis 5/2788 (0.18%)", " Infections and infestations - Other, specify 2/2788 (0.07%)", " Nervous system disorders - Other, specify 0/2788 (0.00%)", " Respiratory, thoracic and mediastinal disorders - Other, specify 1/2788 (0.04%)", " Thromboembolic event 1/2788 (0.04%)", "Adverse Events 2:", " Total: 8/2800 (0.29%)", " Anaphylaxis 5/2800 (0.18%)", " Infections and infestations - Other, specify 0/2800 (0.00%)", " Nervous system disorders - Other, specify 1/2800 (0.04%)", " Respiratory, thoracic and mediastinal disorders - Other, specify 1/2800 (0.04%)", " Thromboembolic event 2/2800 (0.07%)" ]

[ "INCLUSION CRITERIA", " Female", " Histologically-confirmed Her2neu positive breast cancer, by either Immunohistochemistry (IHC) 3+ or Fluorescence In Situ Hybridization (FISH)+", " Stage II/III breast cancer including any large primary tumor (> 2 cm), tumors of any size associated with skin or chest wall involvement, tumors of any size with axillary lymph node involvement, (T2-T4, N0-N2) and those with ipsilateral subclavicular or supraclavicular lymph nodes).", " At least one bi-dimensional, measurable indicator lesion.", " Between 18 and 70 years of age", " Eastern Cooperative Oncology Group (ECOG) performance status 2 / Karnofsky 60% at screening and on the first day of treatment.", " Informed consent must be obtained prior to registration.", " Cardiac ejection fraction within the institutional range of normal as measured by multigated acquisition (MUGA) or echocardiography (ECHO) scan.", " Absolute neutrophil count > 1,500/mm³", " Hemoglobin > 8.0 g/dL", " Platelet count > 100,000/mm³", " Creatinine within normal institutional limits", " Total Bilirubin equal to or less than institutional upper limit of normal (ULN)", " Aspartate aminotransferase (AST); alanine aminotransferase (ALT); and alkaline phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.", " Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of GW572016 will be determined following review of their use by the Principal Investigator", " Antacid use is prohibited 1 hour before and 1 hour after GW572016 dosing.", " All herbal (alternative) medicines are prohibited.", " Medications prohibited during the administration of lapatinib .", " Women of child-bearing potential must have negative pregnancy test and must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation.", " Peripheral neuropathy: must be < grade 1", " Able to swallow and retain oral medication", " EXCLUSION CRITERIA", " Evidence of disease outside the breast or chest wall, except for ipsilateral axillary , supraclavicular, or infraclavicular lymph nodes.", " Prior chemotherapy, immunotherapy, or hormonal therapy for breast cancer.", " More than 3 months between histologic diagnosis and registration on this study.", " History of other malignancy within the last 5years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.", " Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol. Those who are medically-unstable, including but not limited to active infection, acute hepatitis, deep vein thrombosis requiring anticoagulant therapy, gastrointestinal bleeding, uncontrolled hypercalcemia, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome, and those whose circumstances do not permit completion of the study or the required follow-up.", " Congestive heart failure, abnormal left ventricular ejection fraction (LVEF), angina pectoris, uncontrolled cardiac arrhythmias, or other significant heart disease, or who have had a myocardial infarction within the past year.", " Pregnant or lactating", " Of childbearing potential and not employing adequate contraception", " History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.", " HIV-positive and receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.", " GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).", " History of severe hypersensitivity reaction to taxotere or other drugs formulated with polysorbate 80.", " Current active hepatic or biliary disease (with exception of patients with Gilberts syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment )." ]

[ "Outcome Measurement: ", " Safety and Tolerability in Terms of Number of Patients With Adverse Events (Serious and Non-serious)", " [Not Specified]", " Time frame: 3 years, 10 months (Adverse events recorded from patient screening to discontinuation plus 28 days safety follow-up).", "Results 1: ", " Arm/Group Title: AZD4547 80mg bd Cont + Ex 25mg", " Arm/Group Description: 80 mg AZD4547 BD continuous + 25 mg exemestane", " Overall Number of Participants Analyzed: 5", " Measure Type: Number", " Unit of Measure: Participants 5", "Results 2: ", " Arm/Group Title: AZD4547 40mg Cont + Ex 25mg", " Arm/Group Description: 40 mg AZD4547 BD continuous + 25 mg exemestane", " Overall Number of Participants Analyzed: 5", " Measure Type: Number", " Unit of Measure: Participants 5" ]

[ "INTERVENTION 1: ", " Ginkgo Biloba", " Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)", "INTERVENTION 2: ", " Placebo", " Placebo: Patients will take 1 tablet BID" ]

[ "Inclusion criteria:", " DISEASE CHARACTERISTICS:", " Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:", " Dense breast tissue", " At high-risk for breast cancer", " PATIENT CHARACTERISTICS:", " Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:", " Hispanic", " Haitian Creole", " African American", " Caucasian", " PRIOR CONCURRENT THERAPY:", " None specified", "Exclusion criteria:", " No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram" ]

[ "Inclusion Criteria:", " Histologically confirmed Stage IV breast cancer", " Prior banked malignant effusion or significant malignant effusion for tumor harvest or surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan", " Must have received at least one prior regimen of chemotherapy for metastatic disease", " Patients with HER2 positive tumors must have received at least one prior trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab therapy and vaccine treatment concurrently", " Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at any point while on study", " ECOG performance status 0 or 1", " Estimated life expectancy of greater than or equal to 6 months", " 18 years of age or older", " Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy", " Adequate recovery from drug-related toxicities from prior systemic therapies", " Adequate recovery from recent surgery and radiation therapy", " Greater than 6 months since bone marrow or peripheral blood stem cell transplant", "Exclusion Criteria:", " Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days", " Uncontrolled active infection or illness", " Psychiatric illness/social situation that would limit study compliance", " Pregnant or nursing mothers", " Evidence of HIV infection", " Previous participation in an adenovirus-based trial", " Concurrent invasive malignancy" ]

[ "INTERVENTION 1: ", " Experimental", " cyclophosphamide: chemotherapy", " doxorubicin hydrochloride: chemotherapy", " adjuvant therapy: chemotherapy", " radiation therapy: chemotherapy" ]

[ "INTERVENTION 1: ", " Arm A: Nab-Paclitaxel + Gemcitabine", " Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment", "INTERVENTION 2: ", " Arm B: Nab-Paclitaxel + Carboplatin", " Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment." ]

[ "Adverse Events 1:", " Total: 2/15 (13.33%)", " Sinus Tachycardia * 0/15 (0.00%)", " Acute coronary syndrome * 0/15 (0.00%)", " Obstruction Gastric * 0/15 (0.00%)", " Vomiting * 0/15 (0.00%)", " Hemorrhoids * 0/15 (0.00%)", " Nausea * 0/15 (0.00%)", " Duodenal ulcer * 0/15 (0.00%)", " Hepatic pain * 0/15 (0.00%)", " Infections and infestations-other * [1]0/15 (0.00%)", " Lipase Increased * 0/15 (0.00%)", "Adverse Events 2:", " Total: 11/35 (31.43%)", " Sinus Tachycardia * 1/35 (2.86%)", " Acute coronary syndrome * 1/35 (2.86%)", " Obstruction Gastric * 1/35 (2.86%)", " Vomiting * 3/35 (8.57%)", " Hemorrhoids * 1/35 (2.86%)", " Nausea * 3/35 (8.57%)", " Duodenal ulcer * 1/35 (2.86%)", " Hepatic pain * 1/35 (2.86%)", " Infections and infestations-other * [1]1/35 (2.86%)", " Lipase Increased * 1/35 (2.86%)" ]

[ "Inclusion Criteria:", " Biopsy-diagnosed breast cancer with metastasis in multiple organs", " Performance Status (World Health Organization :WHO) 0-2", " Functions below are maintained in major organs:", " Leukocyte count: 4,000/mm3 to 12,000/mm3", " Neutrophil count: >2,000/mm3 or more", " Platelet count: <100,000/mm3 or more", " Hemoglobin: >9.5 g/dL", " Total bilirubin: >1.5 mg/dL", " AST(GOT): within twice a normal upper value in an institution", " AST(GPT): within twice a normal upper value in an institution", " BUN: < 25 mg/dL", " Creatinine: within a normal upper value in the institution", " 24 hours creatinine clearance: >50 mL/min (using the Cockcroft-Gault formula)", " Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85", " Written informed consent will be obtained for patients for entering this study", "Exclusion Criteria:", " Patients with synchronous multiple cancers", " Complicated with infection", " Fever from suspected infection", " Metastasis to the central nerve system", " A history of ischemic cardiac diseases", " Active gastrointestinal ulcer", " Severe nerve disorder", " Women who are potentially pregnant, pregnant, or breast-feeding", " Severe drug allergy", " Severe suppression of the bone marrow", " Severe renal disorder", " Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy)", " Being treated with flucytosine", " Complicated with the infection onset which a study doctor assesses to be inappropriate for this study" ]

[ "Inclusion Criteria:", " Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent", " Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.", " Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.", "Exclusion Criteria:", " Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.", " Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.", " Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting" ]

[ "Adverse Events 1:", " Total: 6/25 (24.00%)", " Supraventricular extrasystoles 1/25 (4.00%)", " Ventricular extrasystoles 1/25 (4.00%)", " Ascites 2/25 (8.00%)", " Diarrhea 1/25 (4.00%)", " Nausea 1/25 (4.00%)", " Pancreatitis 1/25 (4.00%)", " Small intestinal obstruction 1/25 (4.00%)", " Vomiting 1/25 (4.00%)", " Bile duct obstruction 1/25 (4.00%)", " Portal hypertension 1/25 (4.00%)" ]

[ "Adverse Events 1:", " Total: 6/19 (31.58%)", " Febrile neutropenia [1]1/19 (5.26%)", " Fatigue [1]1/19 (5.26%)", " Pyrexia [1]1/19 (5.26%)", " Fracture [1]1/19 (5.26%)", " Hip Fracture [1]1/19 (5.26%)", " Headache [2]1/19 (5.26%)" ]

[ "Inclusion Criteria:", " Female patients with histologically or cytologically confirmed carcinoma of the breast.", " Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.", " Patients with locally recurrent or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least two of which were administered for treatment of locally recurrent and/or metastatic disease.", " Prior therapy must be documented by the following criteria prior to entry onto study:", " Regimens must have included an anthracycline (e.g., doxorubicin, epirubicin) and a taxane (e.g., paclitaxel, docetaxel) in any combination or order. Treatment with any of these agents is not required if they are contraindicated for a certain patient.", " One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy, but at least 2 must have been given for relapsed or metastatic disease.", " Patients must have proved refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy.", " Patients with Human Epidermal Growth Factor 2 (HER2/neu) positive tumors may additionally have been treated with trastuzumab.", " Patients may have additionally been treated with anti-hormonal therapy.", " Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy <= Grade 2 and alopecia.", " Age >= 18 years.", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.", " Life expectancy of >= 3 months.", " Adequate renal function as evidenced by serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 40 mL/min per the Cockcroft and Gault formula.", " Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L, hemoglobin >= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L.", " Adequate liver function as evidenced by bilirubin <= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <= 3 x ULN (in the case of liver metastases <= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. In case alkaline phosphatase is >3 x ULN (in absence of liver metastases) or > 5 x ULN (in presence of liver metastases) AND patient is known to have bone metastases, the liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.", " Patients willing and able to comply with the study protocol for the duration of the study.", " Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.", " EXCLUSION CRITERIA", " Patients who have received any of the following treatments within the specified period before E7389 or TPC treatment start:", " chemotherapy, radiation, trastuzumab or hormonal therapy within three weeks.", " any investigational drug within four weeks.", " Radiation therapy encompassing > 30% of marrow.", " Prior treatment with mitomycin C or nitrosourea.", " Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.", " Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing a contrast-enhanced computed tomography or magnetic resonance imaging brain scan performed during screening to a prior scan performed at least 4 weeks earlier.", " Patients with meningeal carcinomatosis.", " Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy if randomized to E7389 are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.", " Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.", " Severe/uncontrolled intercurrent illness/infection.", " Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).", " Patients with organ allografts requiring immunosuppression.", " Patients with known positive HIV status.", " Patients who have had a prior malignancy, other than previous breast cancer, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence.", " Patients with pre-existing neuropathy > Grade 2.", " Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.", " Patients who participated in a prior E7389 clinical trial whether or not E7389 was received.", " Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study." ]

[ "Outcome Measurement: ", " Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1", " Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.", " Time frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days", "Results 1: ", " Arm/Group Title: Afatinib Monotherapy", " Arm/Group Description: Patient received Afatinib monotherapy orally once daily at a dose of 40 milligram (mg) film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal. Patients could have dose reduced if 40 mg was not tolerated.", " Overall Number of Participants Analyzed: 74", " Measure Type: Number", " Unit of Measure: Percentage of participants 18 (10 to 28)", "Results 2: ", " Arm/Group Title: Afatinib and Paclitaxel or Vinorelbine Combination Therapy", " Arm/Group Description: Patient received Afatinib monotherapy orally once daily at a dose of 40 mg film-coated tablets until progression of their disease, unacceptable adverse events or other reason necessitating withdrawal (Patients could have dose reduced if 40 mg was not tolerated) and 80 mg/square meter (m2) Paclitaxel concentrate for intravenous infusion or 25 mg/m2 Vinorelbine concentrate for intravenous infusion once weekly starting after treatment failure on afatinib monotherapy", " Overall Number of Participants Analyzed: 39", " Measure Type: Number", " Unit of Measure: Percentage of participants 31 (17 to 48)" ]

[ "Inclusion Criteria:", " Female or male patients >=18 years of age.", " Histologically confirmed invasive breast cancer, locally unresectable or metastatic.", " No prior chemotherapy for MBC. Patients may have received adjuvant or", " neoadjuvant chemotherapy (including taxanes and/or bevacizumab) as long as", " treated was completed >12 months prior to relapse. Prior hormonal therapy in the", " adjuvant or metastatic setting will be permitted.", " Prior hormonal therapy in the adjuvant or metastatic setting is permitted. Estrogen receptor positive patients should be considered candidates for chemotherapy.", " HER2-negative breast cancer, defined as follows:", " FISH-negative (FISH ratio <2.2), or", " IHC 0-1+, or", " IHC 2-3+ AND FISH-negative (FISH ratio <2.2).", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.", " Adequate hematologic function, defined by:", " · Absolute neutrophil count (ANC) >1500/mm3", " Platelet count >=100,000/mm3", " Hemoglobin >9 g/dL", " Adequate liver function, defined by:", " · AST and ALT <=2.5 x the upper limit of normal (ULN) or <=5 x ULN in", " presence of liver metastases", " Total bilirubin <=1.5 x ULN", " Adequate renal function, defined by:", " · Serum creatinine <=1.5 x ULN or calculated creatinine clearance of", " >=40 ml/min", " International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial", " thromboplastin time (PTT) within normal limits (WNL) of the institution (if patient is not on anti-coagulation therapy). Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin are eligible if the INR is stable and within the therapeutic range prior to study treatment initiation.", " Adequate lipid profile: total cholesterol <=300 mg/dL OR <=7.75 mmol/L and fasting triglyceride 2.5 x ULN. Note: In case one or both of these thresholds are exceeded,the patient can only be included after initiation of appropriate lipid lowering medication.", " Patients with proteinuria at screening as demonstrated by either:", " · Urine protein creatinine (UPC) ration >1.0 at screening", " or", " Urine dipstick for proteinuria >=2+ (patients discovered to have", " >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour", " urine collection and must demonstrate <1 g of protein in 24 hours to be", " eligible).", " Measurable disease by RECIST criteria.", " Life expectancy >=12 weeks.", " Ability to swallow oral medications.", " Adequate cardiac function, defined by baseline left ventricular ejection fraction (LVEF) value >= normal per institutional guidelines by MUGA scan or", " echocardiogram (ECHO).", " Adequate recovery from recent surgery.", " Major surgical procedure >28 days from study entry", " Minor surgical procedure >7 days from study entry (Portacath placement", " excepted - patients can start treatment <7 days after portacath placement.)", " Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.", " Patient must be accessible for treatment and follow-up.", " All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.", " -", "Exclusion Criteria:", " Patients with active brain metastases or meningeal metastases. Patients who have had brain metastases resected, or have received brain radiation therapy >4 weeks prior to study entry are eligible, if they meet all of the following criteria: 1) residual symptoms < grade 2, 2) no dexamethasone requirement, and 3) follow-up MRI shows regression of lesions after treatment and no new lesions appearing.", " Previous treatment with an m-TOR inhibitor (sirolimus, temsirolimus, everolimus) or anti-angiogenesis agent unless:", " in the adjuvant setting, and", " >=12 months prior to recurrence.", " Previous radiotherapy for metastatic disease completed <2 weeks prior to study treatment initiation.", " Patients who are current receiving systemic cancer therapy or have received", " previous systemic therapy within 4 weeks of the start of study drug (e.g.", " chemotherapy, antibody therapy, targeted agents).", " Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.", " Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or", " diastolic pressure >100 mmHg, despite optimal medical management.", " Concurrent use of CYP3A4 inhibitors and inducers from 72 hours prior to initiation of study treatment until the end of treatment with everolimus.", " Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.", " History of stroke or transient ischemic attack within 6 months prior to first", " bevacizumab dose.", " Patients with any non-healing wound, ulcer, or long-bone fracture.", " Patients with clinical history of hemoptysis or hematemesis.", " Patients with any history of a bleeding diathesis or coagulopathy.", " Patients with a PEG or G tube cannot be enrolled into this trial.", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning bevacizumab.", " Patients with an impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).", " Patients who have any severe and/or uncontrolled medical conditions or other", " conditions that could affect their participation such as:", " severe impaired lung functions as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air", " uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN.", " History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the subject at high risk for treatment complications.", " History of hypersensitivity to Cremophor EL (polyoxyethylated castor oil) or a drug formulated in Cremophor EL, such as paclitaxel.", " Patients may not receive any other investigational or anti-cancer treatments while participating in this study.", " Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.", " Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.", " Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.", " Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or its excipients.", " Patients with a known HIV seropositivity.", "-" ]

[ "Inclusion Criteria:", " Female subjects participating in FMSU004A protocol with known clinical status", "Exclusion Criteria:", " Subjects with unknown clinical status not participating in FMSU004A protocol." ]

[ "Adverse Events 1:", " Total: 63/206 (30.58%)", " Febrile neutropenia * 14/206 (6.80%)", " Neutropenia * 9/206 (4.37%)", " Anaemia * 1/206 (0.49%)", " Leukopenia * 0/206 (0.00%)", " Thrombocytopenia * 1/206 (0.49%)", " Cardiac failure * 0/206 (0.00%)", " Cardiac failure congestive * 1/206 (0.49%)", " Cardiomyopathy * 0/206 (0.00%)", " Coronary artery occlusion * 1/206 (0.49%)", " Coronary artery thrombosis * 0/206 (0.00%)", "Adverse Events 2:", " Total: 72/215 (33.49%)", " Febrile neutropenia * 18/215 (8.37%)", " Neutropenia * 6/215 (2.79%)", " Anaemia * 1/215 (0.47%)", " Leukopenia * 1/215 (0.47%)", " Thrombocytopenia * 0/215 (0.00%)", " Cardiac failure * 1/215 (0.47%)", " Cardiac failure congestive * 0/215 (0.00%)", " Cardiomyopathy * 1/215 (0.47%)", " Coronary artery occlusion * 0/215 (0.00%)", " Coronary artery thrombosis * 1/215 (0.47%)" ]

[ "INTERVENTION 1: ", " Treatment (Neoadjuvant Therapy, Adjuvant Therapy)", " See Detailed Description.", " doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given PO", " paclitaxel: Given IV", " filgrastim: Given SC", " capecitabine: Given PO", " methotrexate: Given IV", " vinorelbine tartrate: Given IV", " needle biopsy: Correlative studies", " therapeutic conventional surgery: Undergo definitive breast surgery", " immunohistochemistry staining method: Correlative studies", " trastuzumab: Given IV", " tamoxifen citrate: Given PO", " letrozole: Given PO", " laboratory biomarker analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " 100 mg Q-122", " Dosage was 100 mg Q-122 administered orally as two 50 mg capsules once daily for 28 days.", "INTERVENTION 2: ", " 200 mg Q-122", " Dosage was 200 mg Q-122 administered orally as four 50 mg capsules once daily for 28 days." ]

[ "INTERVENTION 1: ", " Arm I (Low-dose Omega-3 Fatty Acid)", " Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.", "Omega-3 Fatty Acid: Given PO", " Placebo: Given PO", " Questionnaire Administration: Ancillary studies", " Laboratory Biomarker Analysis: Correlative studies", "INTERVENTION 2: ", " Arm II (High-dose Omega-3 Fatty Acid)", " Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.", "Omega-3 Fatty Acid: Given PO", " Questionnaire Administration: Ancillary studies", " Laboratory Biomarker Analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " Cohort A", " 750mg lapatinib administered orally twice daily. Cohort A subjects had Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and one or two prior trastuzumab-containing regimens, in total, for treatment of breast cancer in adjuvant and/or metastatic settings", "INTERVENTION 2: ", " Cohort B", " 750mg lapatinib administered orally twice daily. Cohort B subjects had ECOG performance status 2 and/or more than 2 prior trastuzumab-containing regimens for treatment of breast cancer in the adjuvant and/or metastatic settings." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed invasive breast cancer meeting the following criteria:", " Primary tumor 3 cm by mammography, ultrasound, or palpation AND/OR palpable axillary lymph nodes > 1 cm", " Survivin- and/or carcinoembryonic antigen-positive by IHC", " Tumor must be localized by exam or ultrasound to allow tumor injection", " No stage IV or metastatic disease", " HER2/neu-negative tumor by IHC", " If 2+ or in the indeterminate range, further testing of HER2/neu overexpression by fluorescent in situ hybridization (FISH) is required", " Hormone receptor status known", " PATIENT CHARACTERISTICS:", " Female", " Pre-, peri-, or postmenopausal", " ECOG performance status 0-1", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception during and for up to 6 months following completion of study therapy", " ANC 1,500/mm³", " Platelet count 100,000/mm³", " Alkaline phosphatase 1.5 times upper limit of normal (ULN)", " Total bilirubin 1.5 times ULN", " AST and ALT 1.5 times ULN", " Creatinine < 1.5 times ULN", " No active serious infections", " No prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which the patient has been disease free for 5 years", " No comorbidity or condition that would interfere with study assessments and procedures or preclude study participation", " PRIOR CONCURRENT THERAPY:", " No prior chemotherapy or radiotherapy" ]

[ "Inclusion Criteria:", " - Female 18 years, 70 years. ECOG 0-1 with no deterioration over previous 2 weeks Minimum life expectancy 3 months Histological confirmation of hormone receptor-high expressed breast cancer(IHC:ER 60% and PR 60%) on primary tumour at diagnosis/on biopsy of metastasis Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis/on biopsy of a metastasis The disease-free time of relapsed patients is more than 12 months Once received standard hormone treatment and progressed Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection At least one evaluative focus according to RECIST creterion or non-measurable disease but only bone metastasis Adequate bone marrow and organ function Progressive disease whilst receiving endocrine therapy for locally advanced or metastatic BC or relapsed with metastatic disease whilst receiving endocrine therapy Radiological or objective clinical evidence of recurrence or progression on or after last systemic therapy prior to enrolment", " 4 prior lines of endocrine therapy for ABC", " 3 line of cytotoxic chemotherapy for ABC Suitable for further endocrine therapy Availability of archival tumour sample or fresh biopsy Informed consent Normal organ function", "Exclusion Criteria:", " Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation <21 days prior to study treatment Last dose of palliative radiotherapy <7 days prior to study treatment Rapidly progressive visceral disease not suitable for further endocrine therapy Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for 4 weeks study treatment Creatinine clearance <30 ml/min. Patients with creatinine clearance <50 mL/min will start at a permanently reduced vandetanib dose of 200 mg.", " Major surgery (excluding placement of vascular access) within 4 weeks before study treatment Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment Elevated ALP in absence of bone metastasis Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent Participation in another study with investigational product during last 30 days Inability or unwillingness to comply with study procedures, including inability to take regular oral medication" ]

[ "Adverse Events 1:", " Total: 5/19 (26.32%)", " Pain 3/19 (15.79%)", " White blood cells (WBC) 5/19 (26.32%)", " Hemoglobin (Hgb) 1/19 (5.26%)", " Absolute neutrophil count (ANC) 5/19 (26.32%)", " Platelets 3/19 (15.79%)", " Elevated Aspartate Aminotransferase (AST) 1/19 (5.26%)", " Elevated Alanine Aminotransferase (ALT) 1/19 (5.26%)", " Dyspnea 3/19 (15.79%)" ]

[ "Adverse Events 1:", " Total: 14/58 (24.14%)", " Constipation 1/58 (1.72%)", " Vomiting 1/58 (1.72%)", " Upper gastrointestinal haemorrhage 1/58 (1.72%)", " Asthenia 1/58 (1.72%)", " Chest pain 1/58 (1.72%)", " Pain 1/58 (1.72%)", " Sepsis 2/58 (3.45%)", " Fall 1/58 (1.72%)", " Spinal compression fracture 1/58 (1.72%)", " Neutrophil count decreased 1/58 (1.72%)", " Dehydration 1/58 (1.72%)", " Hypovolaemia 1/58 (1.72%)" ]

[ "Adverse Events 1:", " Total: 0/0", " Leukopenia 0/0", " Neutropenia 0/0", " Ocular-other 0/0", " Elevated SGPT 0/0", " Arthralgia 0/0", " CNS hemorrhage 0/0", " Neurologic-other 0/0", " Radiation dermatitis 0/0", "Adverse Events 2:", " Total: 11/473 (2.33%)", " Leukopenia 2/473 (0.42%)", " Neutropenia 5/473 (1.06%)", " Ocular-other 1/473 (0.21%)", " Elevated SGPT 1/473 (0.21%)", " Arthralgia 1/473 (0.21%)", " CNS hemorrhage 1/473 (0.21%)", " Neurologic-other 1/473 (0.21%)", " Radiation dermatitis 1/473 (0.21%)" ]

[ "Inclusion Criteria:", " Eligibility Criteria", " Breast cancer diagnosis: Patients must have histologically confirmed adenocarcinoma of the breast requiring comprehensive loco-regional irradiation that includes treatment to the intact breast/chest wall, supraclavicular (SCV), infraclavicular nodes (ICV), and internal mammary nodes (IMN).", " Patients must have pathologic T 1, 2, 3 or 4, N 1, 2, or 3 Stage II or III disease as defined by the AJCC Staging System, 6th edition. Patients who do not undergo axillary staging but are at risk for nodal involvement may also be treated.", " All patients must have left-sided breast cancer.", " Both men and women are eligible.", " Patients must be adults (18 years of age or older)", " For women of child-bearing age, effective contraception must be used. A written statement must be obtained that the patient is not pregnant. If there is any question of pregnancy at time of therapeutic RT or at time of each SPECT-CT scan, a pregnancy test will be done to confirm the patient is not pregnant.", " Performance status should be 0-2 by ECOG criteria.", " Patients that have received prior RT may be enrolled on the present study if the new breast lesion can be treated with no overlap of RT fields.", " Patients must be aware of the neoplastic nature of her/his disease.", " Patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with the Institutional Review Board (IRB) of the University of Michigan and federal guidelines.", " Patients' blood tests should indicate they are able to tolerate radiotherapy. Tests must be done within 28 days of registration:", " CBC with differential and platelet count (Hemoglobin > 8.0 g/dl; wbc > 2000/mm3; absolute neutrophil count > 1000/mm3; platelet count > 75,000/mm3.", "Exclusion Criteria:", " Patients who are pregnant or are nursing are excluded.", " Pathologically node negative breast cancer unless treated with neo-adjuvant chemotherapy.", " Performance status > 2 by ECOG criteria", " Patients who are unable to lie on their back and raise their arm above their head in the treatment planning position for radiotherapy", " Patients with a clinically unstable medical condition", " Patients with a life-threatening disease state", " History or suspicion of serious life-threatening allergic reaction to Tc-99m imaging agents.", " Patients that have had breast-conservation surgery with positive margins or any patient with negative margins with a tumor positive for an extensive intraductal component.", " Patients that are not able to use the ABC device." ]

[ "INTERVENTION 1: ", " CT Plus Trastuzumab", " Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.", "INTERVENTION 2: ", " CT Plus Lapatinib 1500 mg", " Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.", " Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach." ]

[ "INTERVENTION 1: ", " Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)", " Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.", " Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.", " HER-2/neu peptide vaccine: Given ID", " leukapheresis: Undergo leukapheresis", " ex vivo-expanded HER2-specific T cells: Given IV", " cyclophosphamide: Given IV", " sargramostim: Given ID", " laboratory biomarker analysis: Correlative study" ]

[ "INTERVENTION 1: ", " PET Guided Biopsy", " No comparison group. All enrolled participants were expected to undergo PET guided biopsy." ]

[ "Outcome Measurement: ", " Duration of Moderate Neurtopenia Post First Chemotherapy Administration", " Number of days In which the patient has had an absolute neutrophil count (ANC) Level < 2.0 x 10^9/L after first cycle of chemotherapy", " Time frame: The first of 4, 21 Day Chemotherapy Cycles", "Results 1: ", " Arm/Group Title: 80 g/kg/Dose of F-627(TC)", " Arm/Group Description: This dose of F-627 given only to subjects that are to have TC chemotherapy.", " F-627: subcutaneous injection given 1 per chemotherapy.", " Overall Number of Participants Analyzed: 35", " Mean (Standard Deviation)", " Unit of Measure: days 0.6 (1.26)", "Results 2: ", " Arm/Group Title: 240 g/kg/Dose of F-627 (TC)", " Arm/Group Description: This dose of F-627 given to subjects receiving TC or TAC chemotherapy.", " F-627: subcutaneous injection given 1 per chemotherapy.", " Overall Number of Participants Analyzed: 37", " Mean (Standard Deviation)", " Unit of Measure: days 0.6 (1.01)" ]

[ "Outcome Measurement: ", " Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment", " [Not Specified]", " Time frame: 6 months", "Results 1: ", " Arm/Group Title: AC/PTL", " Arm/Group Description: Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.", " Overall Number of Participants Analyzed: 109", " Measure Type: Number", " Unit of Measure: participants 0" ]

[ "DISEASE CHARACTERISTICS:", "Inclusion criteria:", " Histologically proven invasive unilateral breast cancer (regardless of the type)", " Initial clinical condition compatible with complete initial resection", " No residual macro or microscopic tumor after surgical excision", " Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :", " Stage II or III disease", " pT >20 mm (T1-4)", " Patients must meet 1 of the following hormone-receptor criteria:", " Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+)", " Node-negative patients: triple-negative* tumor only", " NOTE: *Hormone-receptor negativity is defined as ER <10% and PR <10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative", " Must be able to begin chemotherapy no later than day 49 after the initial surgery", "Exclusion criteria:", " Clinically or radiologically detectable metastases (M0)", " Bilateral breast cancer or contralateral ductal carcinoma in situ", " Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type", " Any tumor T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)", " HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive", " Any clinically or radiologically suspect and non-explored damage to the contralateral breast", " PATIENT CHARACTERISTICS:", "Inclusion criteria:", " Female", " Pre- or postmenopausal", " ECOG performance status 0-1", " Peripheral neuropathy grade 1", " Neutrophil count 2,000/mm³", " Platelet count 100,000/mm³", " Hemoglobin >9 g/dL", " AST and ALT 1.5 times upper limit of normal (ULN)", " Alkaline phosphatase 2.5 times ULN", " Total bilirubin 1.0 times ULN", " Serum creatinine 1.5 times ULN", " LVEF 50% by MUGA scan or echocardiography", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment", "Exclusion criteria:", " Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer", " Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study", " Clinically significant cardiovascular disease within the past 6 months including any of the following:", " Unstable angina", " Congestive heart failure", " Uncontrolled hypertension (i.e., blood pressure >150/90 mm Hg)", " Myocardial infarction", " Cerebral vascular accidents", " Known prior severe hypersensitivity reactions to agents containing Cremophor EL", " Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule", " Patients deprived of liberty or placed under the authority of a tutor", " PRIOR CONCURRENT THERAPY:", " At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered", " At least 3 weeks since prior major surgery and adequately recovered", " No prior chemotherapy, hormonal therapy, or radiotherapy", " More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:", " Amiodarone", " Clarithromycin", " Amprenavir", " Delavirdine", " Voriconazole", " Erythromycin", " Fluconazole", " Itraconazole", " Ketoconazole", " Indinavir", " Nelfinavir", " Ritonavir", " Saquinavir", " No concurrent participation in another therapeutic trial involving an experimental drug" ]

[ "Inclusion Criteria:", " Histologically confirmed breast cancer with evidence of metastatic disease", " HER2 3+ or FISH (fluorescent in situ hybridization)+", " Age 18 years", " No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.", " No prior chemotherapy in the metastatic setting.", "Exclusion Criteria:", " CNS (central nervous system) metastases", " Prior radiation therapy within the last 4 weeks", " Pregnant (positive pregnancy test) or lactating women", " Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study", " Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study." ]

[ "Outcome Measurement: ", " Number of Participants With Adverse Events (AEs)", " Number of participants with any grade of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Daratumumab", " Time frame: From first dose to 30 days post last dose (up to 34 months)", "Results 1: ", " Arm/Group Title: Nivolumab + Daratumumab (TNBC)", " Arm/Group Description: Triple-negative breast cancer (TNBC) treated with Triple-negative breast cancer (TNBC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)", " Overall Number of Participants Analyzed: 41", " Measure Type: Count of Participants", " Unit of Measure: Participants 41 100.0%", "Results 2: ", " Arm/Group Title: Nivolumab + Daratumumab (NSCLC)", " Arm/Group Description: Non-small cell lung cancer (NSCLC) treated with Nivolumab IV 240 mg Q2W (weeks 3 to 24) + Daratumumab IV 16 mg/kg Q1W (weeks 1 to 8), Daratumumab IV 16 mg/kg Q2W (weeks 9-24)", " Overall Number of Participants Analyzed: 21", " Measure Type: Count of Participants", " Unit of Measure: Participants 21 100.0%" ]

[ "Adverse Events 1:", " Total: 5/11 (45.45%)", " Hemorrhage, GI-abdomen NOS 21/11 (9.09%)", " Pain-liver 21/11 (9.09%)", " Infection-ulcer 20/11 (0.00%)", " Hemoglobin 20/11 (0.00%)", " Hypoglycemia 20/11 (0.00%)", " Pain-rib cage due to vomiting 20/11 (0.00%)", " Obstruction-gu ureter 1/11 (9.09%)", " Hemorrhage gu-bladder 21/11 (9.09%)", " Pain-breast 21/11 (9.09%)", " Pleural effusion 22/11 (18.18%)", "Adverse Events 2:", " Total: 0/6 (0.00%)", " Hemorrhage, GI-abdomen NOS 20/6 (0.00%)", " Pain-liver 20/6 (0.00%)", " Infection-ulcer 20/6 (0.00%)", " Hemoglobin 20/6 (0.00%)", " Hypoglycemia 20/6 (0.00%)", " Pain-rib cage due to vomiting 20/6 (0.00%)", " Obstruction-gu ureter 0/6 (0.00%)", " Hemorrhage gu-bladder 20/6 (0.00%)", " Pain-breast 20/6 (0.00%)", " Pleural effusion 20/6 (0.00%)" ]

[ "Outcome Measurement: ", " Number of Participants With Treatment-Emergent Adverse Events (All Causalities)", " An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.", " Time frame: Baseline up to 28 days after last dose of study treatment, an average of 14 months", "Results 1: ", " Arm/Group Title: Palbociclib+Letrozole India Cohort", " Arm/Group Description: Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information", " Overall Number of Participants Analyzed: 100", " Measure Type: Count of Participants", " Unit of Measure: Participants Participants with adverse events: 92 92.0%", " Participants with serious adverse events: 18 18.0%", " Participants with grade 3 or 4 adverse events: 69 69.0%", " Participants with grade 5 adverse events: 3 3.0%", " Participants discontinued due to adverse events: 2 2.0%", "Results 2: ", " Arm/Group Title: Palbociclib+Letrozole Australia Cohort", " Arm/Group Description: Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information", " Overall Number of Participants Analyzed: 152", " Measure Type: Count of Participants", " Unit of Measure: Participants Participants with adverse events: 152 100.0%", " Participants with serious adverse events: 45 29.6%", " Participants with grade 3 or 4 adverse events: 124 81.6%", " Participants with grade 5 adverse events: 7 4.6%", " Participants discontinued due to adverse events: 9 5.9%" ]

[ "Inclusion Criteria:", " HER2 status must be prospectively, centrally tested and be HER2-positive based on central laboratory assay results", " Histologically or cytologically confirmed invasive breast cancer", " Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent", " Documented progression (which occur during or after most recent treatment or within 6 months after completing of adjuvant therapy) of incurable, unresectable, locally advanced or metastatic breast cancer, defined by the investigator", " Measurable and/or nonmeasurable disease; participants with central nervous system-only disease are excluded", " Cardiac ejection fraction greater than or equal to (>/=) 50 percent (%) by either echocardiogram or multi-gated acquisition scan", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1", " For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception; contraception use should continue for the duration of the study treatment and for at least 6 months after the last dose of study treatment", "Exclusion Criteria:", " History of treatment with trastuzumab emtansine", " Prior treatment with lapatinib or capecitabine", " Peripheral neuropathy of Grade >/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0", " History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer, or cancers with a similar curative outcome as those mentioned above", " History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization except hormone therapy, which could be given up to 7 days prior to randomization; recovery of treatment-related toxicity consistent with other eligibility criteria", " History of radiation therapy within 14 days of randomization", " Brain metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 2 months (60 days) of randomization", " History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment", " History of myocardial infarction or unstable angina within 6 months of randomization", " Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy", " Current severe, uncontrolled systemic disease (for example, clinically significant cardiovascular, pulmonary, or metabolic disease)", " Pregnancy or lactation", " Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus", " Presence of conditions that could affect gastrointestinal absorption: Malabsorption syndrome, resection of the small bowel or stomach, and ulcerative colitis", " History of intolerance (such as Grade 3-4 infusion reaction) to trastuzumab", " Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency", " Current treatment with sorivudine or its chemically related analogs, such as brivudine" ]

[ "Inclusion Criteria:", " Conditions for eligibility for patients with LABC (Cohort A):", " The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.", " Patients must have clinical Stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla that is greater than or equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.", " Conditions for eligibility for patients with resected Stage III breast cancer (Cohort B)", " Patients must have undergone either a total mastectomy or a lumpectomy.", " Patients must have completed one of the following procedures for evaluation of pathologic nodal status.", " Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes, or", " Axillary lymphadenectomy without SN isolation procedure.", " The interval between the last surgery (for breast cancer treatment or staging) and study entry must be no more than 84 days.", " By pathologic evaluation, ipsilateral nodes must be pN2 or pN3.", " For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)", " For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.", " Conditions for patient eligibility (ALL patients)", " The patient must have consented to participate and must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.", " Patients must be female.", " The patient must be greater than or equal to 18 years old.", " The patient's ECOG performance status must be 0 or 1.", " The tumor must be invasive adenocarcinoma of the breast on histologic examination.", " The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using FISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.", " At the time of study entry, blood counts must meet the following criteria:", " Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.", " Platelet count must be greater than/equal to 100,000/mm3.", " Hemoglobin must be greater than/equal to 10 g/dL.", " The following criteria for evidence of adequate hepatic function must be met:", " total bilirubin must be less than/equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and", " alkaline phosphatase must be less than 2.5 x ULN for the lab; and", " AST must be less than/equal to 1.5 x ULN for the lab.", " Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.", " Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (CT, MRI, or PET scan) does not demonstrate metastatic disease, and has adequate hepatic function.", " Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than/equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan or PET scan does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are confirmed as benign by x-ray, MRI, or biopsy.", " Serum creatinine less than/equal to ULN for the lab.", " Urine protein/creatinine (UPC) ratio must be less than 1.0.", " All patients must have their LVEF assessed by 2-D echocardiogram within 3 months prior to study entry. (MUGA scan may be substituted for 2-D echocardiogram based on institutional preferences.) The LVEF must be greater than/equal to 55% regardless of the institution's LLN.", " Note: Since the pre-entry LVEF serves as the baseline for comparing subsequent LVEF assessments to determine if trastuzumab and bevacizumab therapy can be administered, it is critical that this baseline study be an accurate assessment of the patient's LVEF. If the baseline LVEF is greater than 65%, the investigator is encouraged to have the accuracy of the initial LVEF result confirmed and to consider repeating the study if the accuracy is uncertain.", "Exclusion Criteria:", " Conditions for patient ineligibility (Cohort A)", " FNA alone to diagnose the primary tumor.", " Surgical axillary staging procedure prior to study entry. (Procedures that are permitted include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.", " Condition for patient ineligibility (Cohort B)", " Breast reconstruction using tissue expanders or implants at the time of mastectomy.", " Conditions for patient ineligibility (ALL patients)", " Definitive clinical or radiologic evidence of metastatic disease.", " Synchronous bilateral invasive breast cancer.", " History of ipsilateral or contralateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.", " History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.", " Prior therapy with anthracyclines, taxanes, trastuzumab, or bevacizumab for any malignancy.", " Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.", " Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible if these medications are discontinued prior to study entry.)", " Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 6 months after completion of targeted therapy.)", " Cardiac disease that would preclude the use of the drugs included in the FB-5 treatment regimen. This includes but is not confined to:", " Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions controlled by medication; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; and clinically significant valvular disease.", " History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; documented CHF; or documented cardiomyopathy.", " Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater han 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.", " History of hypertensive crisis or hypertensive encephalopathy.", " History of TIA or CVA.", " History of other arterial thrombotic event within 12 months before study entry.", " Symptomatic peripheral vascular disease.", " Any significant bleeding within 6 months before study entry, exclusive of menorrhagia in premenopausal women.", " Serious or non-healing wound, skin ulcers, or bone fracture.", " Gastroduodenal ulcer(s) determined by endoscopy to be active.", " History of GI perforation, abdominal fistulae, or intra-abdominal abscess.", " Anticipation of need for major surgical procedures (other than the breast surgery required for patients in Cohort A) during study therapy and for at least 3 months following completion of bevacizumab.", " Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin.", " Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.", " Sensory/motor neuropathy greater than/equal to grade 2, as defined by the NCI's CTCAE v3.0.", " Conditions that would prohibit administration of corticosteroids.", " History of hypersensitivity reaction to drugs formulated with polysorbate 80.", " Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing should be performed according to institutional standards for women of child-bearing potential.)", " Use of any investigational agent within 4 weeks prior to enrollment in the study.", " Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements." ]

[ "Adverse Events 1:", " Total: 18/52 (34.62%)", " Anaemia 2/52 (3.85%)", " Febrile Neutropenia 1/52 (1.92%)", " Haemolytic Uraemic Syndrome 1/52 (1.92%)", " Leukopenia 1/52 (1.92%)", " Neutropenia 1/52 (1.92%)", " Thrombocytopenia 1/52 (1.92%)", " Cardiac Failure Congestive 1/52 (1.92%)", " Cardio-Respiratory Arrest 1/52 (1.92%)", " Abdominal Pain 1/52 (1.92%)", " Constipation 1/52 (1.92%)", " Diarrhoea 1/52 (1.92%)" ]

[ "Adverse Events 1:", " Total: 14/54 (25.93%)", " anaemia 2/54 (3.70%)", " Febrile neutropenia 7/54 (12.96%)", " Neutropenia 2/54 (3.70%)", " Thrombocytopenia 6/54 (11.11%)", " Atrial fibrillation 1/54 (1.85%)", " Cardiac failure congestive 1/54 (1.85%)", " Pericardial effusion 1/54 (1.85%)", " Nausea 2/54 (3.70%)", " Vomiting 3/54 (5.56%)", " Catheter site erythema 1/54 (1.85%)", " Chest discomfort 1/54 (1.85%)", "Adverse Events 2:", " Total: 5/20 (25.00%)", " anaemia 0/20 (0.00%)", " Febrile neutropenia 2/20 (10.00%)", " Neutropenia 0/20 (0.00%)", " Thrombocytopenia 0/20 (0.00%)", " Atrial fibrillation 0/20 (0.00%)", " Cardiac failure congestive 0/20 (0.00%)", " Pericardial effusion 0/20 (0.00%)", " Nausea 0/20 (0.00%)", " Vomiting 0/20 (0.00%)", " Catheter site erythema 0/20 (0.00%)", " Chest discomfort 0/20 (0.00%)" ]

[ "Adverse Events 1:", " Total: 3/22 (13.64%)", " ascites with hyponatraemia 0/22 (0.00%)", " febrile neutropenia with respiratory infection 1/22 (4.55%)", " urosepsis 1/22 (4.55%)", " febrile neutropenia with urinary tract infection 0/22 (0.00%)", " dyspnoea 1/22 (4.55%)", " hypoxia 0/22 (0.00%)", " thromboembolism 0/22 (0.00%)", "Adverse Events 2:", " Total: 4/17 (23.53%)", " ascites with hyponatraemia 1/17 (5.88%)", " febrile neutropenia with respiratory infection 0/17 (0.00%)", " urosepsis 0/17 (0.00%)", " febrile neutropenia with urinary tract infection 1/17 (5.88%)", " dyspnoea 0/17 (0.00%)", " hypoxia 1/17 (5.88%)", " thromboembolism 1/17 (5.88%)" ]

[ "Adverse Events 1:", " Total: 9/46 (19.57%)", " Febrile neutropenia 1/46 (2.17%)", " Cardiac disorder 1/46 (2.17%)", " Diarrhea 1/46 (2.17%)", " Upper gastrointestinal hemorrhage 1/46 (2.17%)", " Chest pain 1/46 (2.17%)", " Fatigue 1/46 (2.17%)", " Neutrophil count decreased 2/46 (4.35%)", " Platelet count decreased 1/46 (2.17%)", " Anorexia 1/46 (2.17%)", " Dehydration 1/46 (2.17%)", " Serum potassium increased 1/46 (2.17%)" ]

[ "Adverse Events 1:", " Total: 4/6 (66.67%)", " Anemia 0/6 (0.00%)", " Takotsubo cardiomyopathy 1/6 (16.67%)", " Pericardial effusion 0/6 (0.00%)", " Vertigo 1/6 (16.67%)", " Retinal vein occlusion 0/6 (0.00%)", " Gastroenteritis 1/6 (16.67%)", " Vomiting 1/6 (16.67%)", " Diarrhea 0/6 (0.00%)", " Death 2/6 (33.33%)", " Bile duct dilatation 0/6 (0.00%)", " Hepatic hemorrhage 0/6 (0.00%)", "Adverse Events 2:", " Total: 25/52 (48.08%)", " Anemia 1/52 (1.92%)", " Takotsubo cardiomyopathy 0/52 (0.00%)", " Pericardial effusion 2/52 (3.85%)", " Vertigo 0/52 (0.00%)", " Retinal vein occlusion 1/52 (1.92%)", " Gastroenteritis 0/52 (0.00%)", " Vomiting 0/52 (0.00%)", " Diarrhea 1/52 (1.92%)", " Death 9/52 (17.31%)", " Bile duct dilatation 1/52 (1.92%)", " Hepatic hemorrhage 1/52 (1.92%)" ]

[ "INTERVENTION 1: ", " Behavioral Dietary Intervention", " Beginning 2-4 weeks after completion of lumpectomy, patients receive food diaries to complete for 7-10 days. Dietary counselors then give patients guidelines for dietary modifications to reduce caloric intake by 25% of their normal diet. Patients follow caloric restricted diet for 10 weeks (2 weeks prior to radiation therapy, during 6 weeks of radiation therapy, and at least 2 weeks after radiation therapy). Patients undergo radiation therapy QD 5 days a week for 6 weeks.", " Behavioral dietary intervention: Receive caloric restricted dietary intervention", " Therapeutic conventional surgery: Undergo definitive lumpectomy", " Radiation therapy: Undergo radiation therapy", " Counseling intervention: Receive dietary counseling", " Quality-of-life assessment: Ancillary studies" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.", " ECOG performance status of 0 or 1", " For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception", " For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization", "Exclusion Criteria:", " Disease-Specific Exclusions:", " HER2-positive status", " Prior chemotherapy for locally recurrent or metastatic disease", " Prior hormonal therapy < 2 weeks prior to randomization", " Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization", " Investigational therapy within 28 days of randomization", " General Medical Exclusions:", " Life expectancy of < 12 weeks", " Inadequate organ function", " Uncontrolled serious medical or psychiatric illness", " Active infection requiring intravenous (IV) antibiotics at screening", " Pregnancy or lactation", " History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death" ]

[ "DISEASE CHARACTERISTICS:", " Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma", " Largest tumor lesion 5 cm", " Palpable or nonpalpable breast lesion", " Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions", " Prior (preoperative) or planned (intraoperative) sentinel node biopsy required", " At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension", " No clinical evidence of distant metastases", " No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:", " Skeletal pain of unknown cause", " Elevated alkaline phosphatase", " Bone scan showing hot spots", " No palpable axillary lymph node(s)", " No Paget's disease without invasive cancer", " Hormone receptor status:", " Estrogen receptor and progesterone receptor known", " PATIENT CHARACTERISTICS:", " Age", " Any age", " Sex", " Female", " Menopausal status", " Any status", " Performance status", " Not specified", " Life expectancy", " Not specified", " Hematopoietic", " Not specified", " Hepatic", " See Disease Characteristics", " Renal", " Not specified", " Other", " Not pregnant or nursing", " No other prior or concurrent malignancy except the following:", " Adequately treated basal cell or squamous cell skin cancer", " Adequately treated carcinoma in situ of the cervix", " Adequately treated in situ melanoma", " Contralateral or ipsilateral carcinoma in situ of the breast", " No psychiatric, addictive, or other disorder that may compromise ability to give informed consent", " Geographically accessible for follow-up", " PRIOR CONCURRENT THERAPY:", " Biologic therapy", " Not specified", " Chemotherapy", " Not specified", " Endocrine therapy", " Not specified", " Radiotherapy", " Not specified", " Surgery", " See Disease Characteristics", " Other", " No prior systemic therapy for breast cancer", " More than 1 year since prior chemopreventive agent" ]

[ "Inclusion Criteria:", " Adult men and women", " Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer", " Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.", " ECOG Performance Status 0 - 1", " Disease refractory to either, AI, tamoxifen or fulvestrant", " Previously treated on any CDK 4/6 inhibitor.", " Patient has adequate bone marrow and organ function.", "Exclusion Criteria:", " Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.", " Patient has received more than one line of chemotherapy for advanced disease.", " Previous treatment with mTOR inhibitors, or exemestane for advanced disease.", " Progressed on more than one CDK 4/6 inhibitor", " Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.", " Clinically significant, uncontrolled heart disease and/or recent cardiac events." ]

[ "Inclusion Criteria:", " Female participants aged 18 years or older who are postmenopausal.", " Histologically proven diagnosis of breast cancer with evidence of metastatic disease or locoregional recurrence.", " Histological confirmation and documentation of estrogen receptor (ER)-positive status ( 1% positive stained cells).", " Histological or cytological confirmation and documentation of human epidermal growth factor receptor-2 (HER2)-negative status by local laboratory testing using criteria in the American Society of Oncology (ASCO)/College of American Pathologists (CAP) Clinical Practice Guideline update.", " Measurable disease defined as either of the following:", " At least 1 extra-osseous lesion that could be accurately measured in at least 1 dimension.", " The lesion must have measured 20 mm with conventional imaging techniques or 10 mm with spiral CT or MRI. Lymph nodes must be 1.5 cm in the short axis to be considered measurable.", " Bone lesions (lytic or mixed [lytic plus sclerotic]) in the absence of measurable disease as defined above. Note: Participants with sclerotic/osteoblastic bone lesions only, in the absence of measurable disease, were not eligible.", " Progressive Disease (PD) during prior aromatase inhibitor (AI) therapy.", " Have a history of brain metastasis provided that all of the following criteria are met:", " Brain metastases have been treated.", " No evidence of PD for 3 months before the first dose of study drug.", " No hemorrhage after treatment.", " Off dexamethasone treatment for 4 weeks before the first dose of study drug.", " No ongoing requirement for dexamethasone or anti-epileptic drugs.", " Eastern cooperative oncology group (ECOG) performance status of 0 or 1.", " Clinical laboratory values as specified below within 4 weeks before the first dose of study drug:", " Bone marrow reserve consistent with absolute neutrophil count (ANC) 1.5*10^9/L; platelet count 100*10^9/L; hemoglobin (Hgb) 9 g/dL.", " Total bilirubin 1.5*the upper limit of the normal range (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5*ULN ( 5*ULN if liver metastases are present).", " Creatinine clearance 40 mL/min based on Cockcroft-Gault estimate or based on a 12- or 24-hour urine collection.", " Fasting serum glucose 130 mg/dL and fasting triglycerides 300 mg/dL.", "Exclusion Criteria:", " Prior therapy with mechanistic target of rapamycin (mTOR), phosphoinositide-3-kinase (PI3K), or dual PI3K-mTOR inhibitors, serine/threonine-specific protein kinase (AKT) inhibitors, or fulvestrant.", " Prior treatment with >1 line of chemotherapy for metastatic breast cancer or for locoregional recurrence that was not amenable to resection or radiation therapy with curative intent.", " Experienced PD on >2 endocrine therapies for metastatic breast cancer or for locoregional recurrence that was not amenable to resection or radiation therapy with curative intent.", " Life-threatening metastatic visceral disease (defined as extensive hepatic involvement or symptomatic pulmonary lymphangitic spread).", " Poorly controlled diabetes mellitus defined as hemoglobin A1c (glycosylated hemoglobin; HbA1c) >7%; participants with a history of transient glucose intolerance due to corticosteroid administration may be eligible if all other inclusion/exclusion criteria are met." ]

[ "Adverse Events 1:", " Total: 4/6 (66.67%)", " Anemia 0/6 (0.00%)", " Takotsubo cardiomyopathy 1/6 (16.67%)", " Pericardial effusion 0/6 (0.00%)", " Vertigo 1/6 (16.67%)", " Retinal vein occlusion 0/6 (0.00%)", " Gastroenteritis 1/6 (16.67%)", " Vomiting 1/6 (16.67%)", " Diarrhea 0/6 (0.00%)", " Death 2/6 (33.33%)", " Bile duct dilatation 0/6 (0.00%)", " Hepatic hemorrhage 0/6 (0.00%)", "Adverse Events 2:", " Total: 25/52 (48.08%)", " Anemia 1/52 (1.92%)", " Takotsubo cardiomyopathy 0/52 (0.00%)", " Pericardial effusion 2/52 (3.85%)", " Vertigo 0/52 (0.00%)", " Retinal vein occlusion 1/52 (1.92%)", " Gastroenteritis 0/52 (0.00%)", " Vomiting 0/52 (0.00%)", " Diarrhea 1/52 (1.92%)", " Death 9/52 (17.31%)", " Bile duct dilatation 1/52 (1.92%)", " Hepatic hemorrhage 1/52 (1.92%)" ]

[ "Adverse Events 1:", " Total: 13/50 (26.00%)", " Febrile neutropenia 3/50 (6.00%)", " Neutropenia 1/50 (2.00%)", " Pancreatitis 1/50 (2.00%)", " Cholangitis 1/50 (2.00%)", " Cholelithiasis 1/50 (2.00%)", " Anaphylactic reaction [1]1/50 (2.00%)", " Pneumonia 1/50 (2.00%)", " Pneumonitis chemical 1/50 (2.00%)", " Spinal compression fracture 1/50 (2.00%)", " Dehydration 1/50 (2.00%)", " Electrolyte imbalance 1/50 (2.00%)" ]

[ "Adverse Events 1:", " Total: 1/3 (33.33%)", " FEBRILE NEUTROPENIA 0/3 (0.00%)", " LYMPH NODE PAIN 0/3 (0.00%)", " NEUTROPHIL COUNT DECREASED 0/3 (0.00%)", " THROMBOCYTOPENIA 0/3 (0.00%)", " CHEST PAIN 0/3 (0.00%)", " DEHYDRATION 0/3 (0.00%)", " PLEURAL EFFUSION 1/3 (33.33%)", " PNEUMONITIS 0/3 (0.00%)", " PULMONARY INFILTERATES 0/3 (0.00%)", " ALOPECIA 0/3 (0.00%)" ]

[ "Inclusion Criteria:", " Age: no limit", " Karnofsky performance status (KPS) 70", " No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).", " The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol.", " Previously treated lesions are not eligible unless the prescribed dose can be safely delivered.", " Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.", " Informed consent must be obtained.", " Pregnancy test must be negative for women of child bearing potential", "Exclusion Criteria:", " Inability of patient to be followed longitudinally as specified by protocol.", " Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.", " Women who are pregnant or nursing.", " Failure to meet requirements in Inclusion Criteria", " Contraindications to radiation." ]

[ "DISEASE CHARACTERISTICS:", " Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:", " Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy", " May or may not have elevated CA 15-3 or CEA levels", " Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels", " Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart", " For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart", " Stage III and completed adjuvant therapy no more than 24 months ago", " Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy", " Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection", " Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago", " Stage IV that is stable on hormonal therapy", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age:", " 18 and over", " Sex:", " Male or female", " Menopausal status:", " Not specified", "Performance status:", " Karnofsky 80-100%", " Life expectancy:", " Not specified", " Hematopoietic:", " Lymphocyte count at least 500/mm^3", " WBC at least 3,000/mm^3", " Hepatic:", " AST no greater than 1.5 times upper limit of normal (ULN)", " Alkaline phosphatase no greater than 1.5 times ULN", " Renal:", " Creatinine no greater than 1.5 times ULN", " Cardiovascular:", " No clinically significant New York Heart Association class III or IV cardiac disease", " Other:", " Not pregnant", " Negative pregnancy test", " Fertile patients must use effective contraception", " No prior seafood allergy", " No known prior immunodeficiency or autoimmune disease", " No other active cancer except basal cell or squamous cell skin cancer", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " At least 6 weeks since prior immunotherapy", " No prior vaccine with any of the antigens in this study", " Chemotherapy:", " See Disease Characteristics", " At least 4 weeks since prior chemotherapy", " No concurrent chemotherapy", " Endocrine therapy:", " See Disease Characteristics", " Radiotherapy:", " See Disease Characteristics", " At least 4 weeks since prior radiotherapy", " No concurrent radiotherapy", " Surgery:", " See Disease Characteristics", " At least 4 weeks since prior surgery", " Concurrent surgery for local recurrence allowed if patient remains disease free" ]

[ "Inclusion Criteria:", " Histologically confirmed breast cancer with accompanying pathology report;", " Submit unstained representative tumor specimen, either as a paraffin block (preferred) or 10 unstained slides", " Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);", " Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;", " Estimated life expectancy of at least 3 months", "Exclusion Criteria:", " Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;", " Pregnant or lactating;", " Known or suspected brain metastasis or leptomeningeal disease;", " History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;", " For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor." ]

[ "Inclusion Criteria:", " Pathologically and radiologically confirmed metastatic triple negative breast cancer", " Up to two prior lines of chemotherapy for metastatic breast cancer", " Availability of a representative tumor specimen", " At least one measurable lesion", "Exclusion Criteria:", " Have received previous treatment with PI3K inhibitors", " Symptomatic central nervous system (CNS) metastases (controlled and asymptomatic CNS metastases are acceptable)", " Concurrent malignancy or has a malignancy within 3 years of study enrollment", " Any of the following mood disorders: active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, homicidal ideation, greater than or equal to Common Toxicity Criteria for Adverse Events (CTCAE) grade 3 anxiety", " Concurrently using other approved or investigational antineoplastic agent and/or chemotherapy within 21 days prior to enrollment in this study", " Has received radiation therapy within 28 days prior to enrollment in this study or has not recovered from side effects of such therapy", " Major surgery within 28 days of starting therapy or has not recovered from major side effects of a previous surgery", " Poorly controlled diabetes mellitus", " History of cardiac dysfunction", " Currently receiving treatment with QT prolonging medication and the treatment cannot be discontinued or switched to a different medication", " Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120", " Receiving chronic treatment with steroids or another immunosuppressive agent", " Other concurrent severe and/or uncontrolled medical condition that would contraindicate participation in this study", " History of non-compliance to a medical regimen", " Currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme Cytochrome P450, family 3, subfamily A (CYP3A)", " Known history of human immunodeficiency virus (HIV)", " Pregnant or breastfeeding", " Unwilling to observe total abstinence or to use double barrier method for birth control throughout trial" ]

[ "INTERVENTION 1: ", " Arm I (Omega-3-fatty Acid)", " Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity", "INTERVENTION 2: ", " Arm II (Placebo)", " Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity" ]

[ "INTERVENTION 1: ", " Accelerated Partial Breast Brachytherapy", " Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.", " Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions." ]

[ "Adverse Events 1:", " Total: 45/298 (15.10%)", " Febrile neutropenia * 10/298 (3.36%)", " Neutropenia * 9/298 (3.02%)", " Leukopenia * 0/298 (0.00%)", " Thrombocytopenia * 0/298 (0.00%)", " Lymphadenopathy * 1/298 (0.34%)", " Cardiac failure congestive * 0/298 (0.00%)", " Arrhythmia * 0/298 (0.00%)", " Myocardial infarction * 1/298 (0.34%)", " Angina pectoris * 1/298 (0.34%)", " Atrial fibrillation * 0/298 (0.00%)", "Adverse Events 2:", " Total: 65/297 (21.89%)", " Febrile neutropenia * 13/297 (4.38%)", " Neutropenia * 7/297 (2.36%)", " Leukopenia * 1/297 (0.34%)", " Thrombocytopenia * 1/297 (0.34%)", " Lymphadenopathy * 0/297 (0.00%)", " Cardiac failure congestive * 2/297 (0.67%)", " Arrhythmia * 1/297 (0.34%)", " Myocardial infarction * 1/297 (0.34%)", " Angina pectoris * 0/297 (0.00%)", " Atrial fibrillation * 1/297 (0.34%)" ]

[ "Adverse Events 1:", " Total: 2/38 (5.26%)", " Febrile neutropenia 0/38 (0.00%)", " Abdominal pain 1/38 (2.63%)", " Skin infection 0/38 (0.00%)", " Seizure 1/38 (2.63%)" ]

[ "Adverse Events 1:", " Total: 4/42 (9.52%)", " Perforation, GI 1/42 (2.38%)", " Febrile neutropenia 1/42 (2.38%)", " Syncope 1/42 (2.38%)", " Rash/desquamation 1/42 (2.38%)" ]

[ "Inclusion Criteria:", " Patients with histologic confirmation of invasive breast carcinoma.", " Patients must have intact primary tumor.", " Patients greater than or equal to 18 years.", " Patients should have T1N1-3M0 or T2-4 N0-3M0.", " Patients with bilateral breast cancer are eligible.", " Patients with second primary breast cancers are eligible.", " Patients should have a Karnofsky performance scale of greater than or equal to 70%.", " Patients must have clinically measurable disease to be treated in the neoadjuvant setting.", " Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of greater than or equal to 1500/mm^3, and platelet count greater than or equal to 100000mm^3.", " Patients must have adequate liver function with a bilirubin within normal laboratory values. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upper limit of normal (ULN) of the institution.", " Patients should have adequate renal function with creatinine levels within normal range.", " Patients should have a normal left ventricular ejection fraction (LVEF) of greater than or equal to 50%.", " Negative serum or urine pregnancy test for a woman of childbearing potential (WOCBP).", " WOCBP must use a reliable and appropriate contraceptive method during the study and six months after chemotherapy is completed. WOCBP are women who are not menopausal for 12 months or had no previous surgical sterilization.", " Patients must agree to have study biopsies.", " Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy.", "Exclusion Criteria:", " Patients with a history of other invasive malignancies diagnosed and treated within the previous 5 years, except non-melanoma skin cancer and non-invasive cervical cancer.", " Her2Neu, ER and PR positive patients should be excluded.", " Patients with Inflammatory breast cancer (IBC) are excluded.", " Patients with an organ allograft or other history of immune compromise.", " Prior treatment with any investigational drug within the preceding 4 weeks.", " Chronic treatment with systemic steroids or another immunosuppressive agent.", " A Known history of HIV seropositivity.", " Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin defined as 1 mg a day).", " Other concurrent and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration).", " Patients with a pre-existing peripheral neuropathy." ]

[ "INTERVENTION 1: ", " Anastrozole and Simvastatin", " adjuvant therapy : laboratory analysis", " pharmacological study : laboratory analysis", " simvastatin : 40 milligram tablet PO QD for 14 days", " anastrozole : 1 milligram tablet PO QD for 14 days" ]

[ "Adverse Events 1:", " Total: 5/41 (12.20%)", " Neutropenia 4/41 (9.76%)", " Febrile Neutropenia 0/41 (0.00%)", " SGPT (ALT) 1/41 (2.44%)", "Adverse Events 2:", " Total: 5/40 (12.50%)", " Neutropenia 4/40 (10.00%)", " Febrile Neutropenia 1/40 (2.50%)", " SGPT (ALT) 0/40 (0.00%)" ]

[ "DISEASE CHARACTERISTICS:", " Diagnosis of localized breast cancer", " Stage I-IIIA disease", " Adequately treated breast cancer", " No clinical or radiological evidence of recurrent or metastatic disease", " Baseline total lumbar spine or femoral neck bone mineral density T-score < -2.0 standard deviation (e.g., a patient with a T score of -2.1 is eligible)", " Hormone-receptor status:", " Estrogen receptor and/or progesterone receptor-positive breast cancer", " PATIENT CHARACTERISTICS:", " Female", " Postmenopausal, defined by 1 of the following criteria:", " Age > 55 years with cessation of menses", " Age 55 years with spontaneous cessation of menses for > 1 year", " Age 55 years with spontaneous cessation of menses for 1 year, but amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND has postmenopausal estradiol levels", " Bilateral oophorectomy", " ECOG performance status 0-2", " Life expectancy 5 years", " WBC 3,000/mm³ OR granulocyte count 1,500/mm³", " Platelet count 100,000/mm³", " Alkaline phosphatase 3 times upper limit of normal (ULN)", " AST 3 times ULN", " Creatinine < 2.0 mg/dL", " Creatinine clearance 45 mL/min", " No hypercalcemia (i.e., calcium level > 1 mg/dL above ULN) OR hypocalcemia (i.e., calcium level > 0.5 mg/dL below lower limit of normal) within the past 6 months", " No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix", " No other nonmalignant systemic diseases, including any of the following:", " Uncontrolled infection", " Uncontrolled diabetes mellitus", " Uncontrolled thyroid dysfunction", " Disease affecting bone metabolism (hyperparathyroidism, hypercortisolism, Paget's disease, osteogenesis imperfecta)", " Malabsorption syndrome", " No uncontrolled seizure disorders associated with falls", " No known hypersensitivity to zoledronate or other bisphosphonates, letrozole, calcium, or vitamin D", " No concurrent active dental problems, including any of the following:", " Infection of the teeth or jawbone (maxillary or mandibular)", " Dental or fixture trauma", " Prior or current diagnosis of osteonecrosis of the jaw", " Exposed bone in the mouth", " Slow healing after dental procedures", " No contraindication to spine dual energy x-ray absorptiometry (DXA) as defined by any of the following:", " History of surgery at the lumbosacral spine, with or without implantable devices", " Scoliosis with a Cobb angle > 15 degrees at the lumbar spine", " Immobility, hyperostosis, or sclerotic changes at the lumbar spine, or evidence of sclerotic abdominal aorta sufficient to interfere with DXA scan", " Disease of the spine that would preclude the proper acquisition of a lumbar spine DXA", " No condition that would preclude study follow-up or compliance", " No psychiatric illness that would preclude giving informed consent", " PRIOR CONCURRENT THERAPY:", " More than 3 weeks since prior and no other concurrent oral bisphosphonates", " No prior intravenous bisphosphonates", " No prior aromatase inhibitor therapy", " More than 6 months since prior anabolic steroids or growth hormone", " More than 2 weeks since prior and no concurrent inhibitor of osteoclastic bone resorption (e.g., calcitonin, mithramycin, or gallium nitrate)", " More than 30 days since prior systemic investigational drug and/or device", " More than 7 days since prior topical investigational drug", " More than 6 weeks since prior and no concurrent dental or jaw surgery (e.g., extraction, implants)", " Concurrent short-term corticosteroid therapy allowed", " No concurrent sodium fluoride, parathyroid hormone, or tibolone", " No other concurrent investigational drug or device" ]

[ "INTERVENTION 1: ", " Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)", " Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.", " vorinostat: Given PO", " laboratory biomarker analysis: Correlative studies", " biopsy: Optional correlative studies", " F-18 16 alpha-fluoroestradiol: Correlative studies", " positron emission tomography: Correlative studies", " anastrozole: Given PO", " letrozole: Given PO", " exemestane: Given PO", " gene expression analysis: Correlative studies" ]

[ "INTERVENTION 1: ", " 6-Mercaptopurine and Methotrexate (6MP/MTX)", " 6-Mercaptopurine: 6MP 75mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression.", " Methotrexate: Methotrexate 20mg/m2 will be taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.", " Update: These original doses were reduced following an Urgent Safety Measure in August 2012 due to a large proportion of patients requiring a dose reduction or treatment delay due to incidences of myelo-suppression.", " The reduced doses were 55mg/m2 of 6MP orally once a day, and 15mg/m2 of Methotrexate orally once a week." ]

[ "Inclusion Criteria:", " Females 18 years of age", " Histologically confirmed breast cancer that is HER2/neu positive (3+ by IHC or FISH +) and evidence of metastatic disease. Tumor may be of any estrogen and progesterone receptor type", " Measurable disease by RECIST and an ECOG 2", " Patients with known evidence of brain metastases are eligible if they are asymptomatic and have completed all therapy (surgery, radiotherapy, and/or steroids)", " Baseline LVEF value within the institutional normal range", " Any number of prior hormonal therapy treatments in the adjuvant setting or for metastatic disease. A subject must have progressed on hormonal therapy and all hormonal therapy (including birth control pills) must be discontinued at study entry.", " Prior chemotherapy in the adjuvant setting and up to one prior chemotherapy regimen for metastatic disease is allowed.", " Patients may have received one prior trastuzumab/chemotherapy containing regimen or prior single agent trastuzumab.", " Prior radiation therapy in the adjuvant setting or for metastatic disease, provided it was not to the only site of evaluable disease.", " All prior chemotherapy, trastuzumab and radiation therapy should be completed > 2 weeks before enrollment.", " Patients receiving bisphosphonate therapy are eligible. However, if bisphosphonate were started within < 2 months prior to enrollment, the bone lesions will not be evaluated for response and the patient must have another site of metastatic disease that is either measurable or evaluable for response.", " Patients must have recovered from toxicities due to prior therapy.", " Lab values in accordance with the protocol", " Patients must be nonpregnant and nonlactating. Patients of childbearing potential must implement an effective method of contraception during the study (birth control pills are not allowed).", "Exclusion Criteria:", " Bone only disease are ineligible", " Patients who received more than 1 prior chemotherapy regimen for metastatic disease are ineligible.", " Patients with a history of other cancers except curatively-treated carcinoma of the cervix in situ or non-melanomatous skin cancer.", " Active serious infection or other underlying medical condition that would impair their ability to receive protocol treatment.", " Uncontrolled nervous system metastases", " Dementia or significantly altered mental status that would interfere with proper consenting.", " Receiving other investigational therapy." ]

[ "Inclusion Criteria:", " All tumors must be ER-, PR- and HER2-negative", " Clinical stage T2 or T3, N0-3, M0. Subjects with inflammatory breast cancer are not eligible", " For subjects with clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject's physicians; for subjects with a clinically positive axilla, a needle aspiration or core biopsy will be performed to confirm the presence of metastatic disease in the lymph nodes.", " 18 years of age or older", " Performance status (PS) of 0 or 1", " Use of an effective means of contraception in subjects of child-bearing potential", " Normal organ function as described in the protocol", "Exclusion Criteria:", " Any prior cytotoxic chemotherapy or radiation for the current breast cancer", " HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS)or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer", " Life expectancy of less than 12 weeks", " Current, recent, or planned participation in an experimental durg study other than a Genentech-sponsored bevacizumab cancer study", " Renal dysfunction for which exposure to cisplatin would require dose modifications", " Steroid dependent asthma", " Peripheral neuropathy of any etiology that exceeds grade 1", " Uncontrolled diabetes", " History of malignancy treated without curative intent", " Any other pre-existing medical condition that would represent toxicity in excess of grade 1", " Inadequately controlled hypertension", " Any prior history of hypertensive crisis or hypertensive encephalopathy", " New York Heart Association (NYHA) Grade II or greater congestive hear failure", " History of myocardial infarction or unstable angina within 12 months prior to study enrollment", " Any history of stroke or transient ischemic attack at any time", " Known central nervous system (CNS) disease", " Significant vascular disease", " Symptomatic peripheral vascular disease", " Evidence of bleeding diathesis or coagulopathy", " Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to study enrollment", " History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study enrollment", " Serious, non-healing wound, ulcer or bone fracture", " Proteinuria at screening", " Known hypersensitivity to any component of bevacizumab", " Pregnant or lactating" ]

[ "INTERVENTION 1: ", " Group I (Topical Keratin)", " Patients receive topical keratin topically at least BID until the end of radiation therapy (approximately 3-6 weeks).", " Quality-of-Life Assessment: Ancillary studies", " Topical Keratin: Given topically", "INTERVENTION 2: ", " Group II (Standard of Care)", " Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).", " Best Practice: Receive standard of care", " Quality-of-Life Assessment: Ancillary studies" ]

[ "Inclusion Criteria:", " Female gender", " Age 18 years", " An invasive primary breast cancer of any histology arising from breast parenchyma", " Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection", " Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is 1 and M stage is 0.", " Patient signed study-specific consent form.", "Exclusion Criteria:", " Patients with distant metastasis.", " Patients who are pregnant or breastfeeding.", " Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.", " Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months.", " Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist.", " Prior radiation therapy to the ipsilateral or contralateral breast or thorax.", " Primary breast cancer is a lymphoma or sarcoma histology.", " Patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer.", " Patients requiring radiation to the bilateral breasts." ]

[ "Adverse Events 1:", " Total: 30/98 (30.61%)", " NEUTROPENIA 1/98 (1.02%)", " ATRIAL FIBRILLATION 1/98 (1.02%)", " CARDIAC FAILURE 1/98 (1.02%)", " TACHYCARDIA 0/98 (0.00%)", " ACUTE VESTIBULAR SYNDROME 1/98 (1.02%)", " VERTIGO 0/98 (0.00%)", " ABDOMINAL PAIN 0/98 (0.00%)", " COLITIS 0/98 (0.00%)", " DIARRHOEA 2/98 (2.04%)", " FEMORAL HERNIA 0/98 (0.00%)", " HAEMATEMESIS 0/98 (0.00%)", " ILEUS 0/98 (0.00%)", " NAUSEA 0/98 (0.00%)", "Adverse Events 2:", " Total: 46/102 (45.10%)", " NEUTROPENIA 0/102 (0.00%)", " ATRIAL FIBRILLATION 0/102 (0.00%)", " CARDIAC FAILURE 0/102 (0.00%)", " TACHYCARDIA 2/102 (1.96%)", " ACUTE VESTIBULAR SYNDROME 0/102 (0.00%)", " VERTIGO 1/102 (0.98%)", " ABDOMINAL PAIN 2/102 (1.96%)", " COLITIS 1/102 (0.98%)", " DIARRHOEA 8/102 (7.84%)", " FEMORAL HERNIA 1/102 (0.98%)", " HAEMATEMESIS 1/102 (0.98%)", " ILEUS 1/102 (0.98%)" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed breast cancer meeting 1 of the following criteria:", " Unresectable stage IIIB or IIIC disease", " Stage IV disease", " Must be negative for all of the following:", " Estrogen receptor (< 10%)", " Progesterone receptor (<10%)", " HER-2 (negative FISH, IHC 0 - 1+, or IHC +2 with negative FISH)", " Measurable or evaluable disease", " No symptomatic or progressive CNS (central nervous system) metastases", " Previously treated CNS metastases allowed provided all of the following criteria are met:", " At least 8 weeks since prior radiation to brain or CNS metastases", " No concurrent steroids", " No leptomeningeal disease", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " ECOG (Eastern Cooperative Oncology Group) performance status 0-2", " Life expectancy 6 months", " WBC > 1,500/mm³", " Platelet count > 100,000/mm³", " Creatinine clearance > 40 mL/min", " Normal electrolytes (i.e., Na, K, and Ca normal; minor deviations are allowed if they do not impact on patient safety in the clinical judgment of the treating physician)", " Bilirubin 1.5 times upper limit of normal (ULN)", " ALT and AST 2.5 times ULN ( 5 times ULN in the presence of documented liver metastases)", " Alkaline phosphatase 2.5 times ULN ( 5 times ULN in the presence of liver or bone metastases)", " Not pregnant or nursing", " Fertile patients must use effective barrier contraception", " No uncontrolled intercurrent illness", " No active infection requiring systemic therapy", " Able to swallow oral medications and with no medical problems or prior surgeries that may interfere with the absorption of oral medications including the following:", " Uncontrolled nausea, vomiting, or diarrhea", " Lack of the physical integrity of the upper gastrointestinal tract", " Malabsorption syndrome", " No known hypersensitivity to bendamustine hydrochloride, mannitol, or erlotinib hydrochloride", " No prior malignancy in the past 5 years except for adequately treated basal cell or squamous cell skin carcinoma, or adequately treated stage I-II cancer for which the patient is in complete remission", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Prior adjuvant or neoadjuvant chemotherapy and 1 prior chemotherapy regimen in the metastatic setting allowed provided recovered from all acute toxicities", " No prior bendamustine hydrochloride or EGFR-directed therapy", " No other concurrent antineoplastic treatments, including radiotherapy, chemotherapy, biological therapy, hormonal therapy, immunotherapy, gene therapy, and surgery", " Intravenous bisphosphonates allowed", " No concurrent antiretroviral therapy for HIV-positive patients", " No other concurrent investigational agents" ]

[ "Adverse Events 1:", " Total: 11/50 (22.00%)", " Anemia 3/50 (6.00%)", " Febrile neutropenia 1/50 (2.00%)", " Arrythmia 1/50 (2.00%)", " Ileus 1/50 (2.00%)", " Nausea 1/50 (2.00%)", " Pain-Abdominal 1/50 (2.00%)", " Vomiting 1/50 (2.00%)", " Bronchial infection 1/50 (2.00%)", " Sepsis 1/50 (2.00%)", " Neutropenia 2/50 (4.00%)", " Platelet count decreased 1/50 (2.00%)", " Dehydration 1/50 (2.00%)", " Arthralgia 1/50 (2.00%)" ]

[ "Adverse Events 1:", " Total: 20/101 (19.80%)", " Neutropenia * 2/101 (1.98%)", " Febrile neutropenia * 1/101 (0.99%)", " Pericardial effusion * 2/101 (1.98%)", " Abdominal distension * 1/101 (0.99%)", " Abdominal pain * 1/101 (0.99%)", " Ascites * 1/101 (0.99%)", " Gastritis * 1/101 (0.99%)", " Asthenia * 1/101 (0.99%)", " Pyrexia * 1/101 (0.99%)", " Pneumonia * 1/101 (0.99%)", " Pseudomonal sepsis * 1/101 (0.99%)" ]

[ "Adverse Events 1:", " Total: 3/6 (50.00%)", " Febrile neutropenia 0/6 (0.00%)", " Leukopenia 0/6 (0.00%)", " Neutropenia 0/6 (0.00%)", " Thrombocytopenia 0/6 (0.00%)", " Cardio-respiratory arrest 0/6 (0.00%)", " Cardiopulmonary failure 0/6 (0.00%)", " Vertigo 0/6 (0.00%)", " Visual impairment 0/6 (0.00%)", " Abdominal pain 0/6 (0.00%)", " Diarrhoea 0/6 (0.00%)", " Dysphagia 0/6 (0.00%)", " Gastric ulcer 0/6 (0.00%)", "Adverse Events 2:", " Total: 6/17 (35.29%)", " Febrile neutropenia 0/17 (0.00%)", " Leukopenia 0/17 (0.00%)", " Neutropenia 0/17 (0.00%)", " Thrombocytopenia 0/17 (0.00%)", " Cardio-respiratory arrest 1/17 (5.88%)", " Cardiopulmonary failure 0/17 (0.00%)", " Vertigo 0/17 (0.00%)", " Visual impairment 0/17 (0.00%)", " Abdominal pain 0/17 (0.00%)", " Diarrhoea 1/17 (5.88%)", " Dysphagia 0/17 (0.00%)", " Gastric ulcer 1/17 (5.88%)" ]

[ "DISEASE CHARACTERISTICS:", " Histologically proven invasive carcinoma of the breast", " No evidence of T4, N2-3, or M1 disease prior to surgery", " Node positive or high-risk node negative", " Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT", " Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision", " Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site", " Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria", " If node positive, then a level I and II axillary dissection must be performed", " No evidence of residual disease in axilla after dissection", " Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy", " High risk of regional and systemic recurrence due to one of the following:", " Pathologically positive axillary lymph nodes", " Pathologically negative axillary lymph nodes with one of the following:", " Primary tumor greater than 5 cm", " Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:", " Estrogen receptor negative", " Skarf-Bloom-Richardson grade 3", " Lymphovascular invasion", " Hormone receptor status:", " Estrogen and progesterone receptor status known", " PATIENT CHARACTERISTICS:", " Age:", " 16 and over", " Sex:", " Female", " Menopausal status:", " Premenopausal or postmenopausal", "Performance status:", " ECOG 0-2", " Life expectancy:", " At least 5 years", " Hematopoietic:", " Not specified", " Hepatic:", " SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)*", " Alkaline phosphatase no greater than 3 times ULN* NOTE: * Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations", " Renal:", " No serious nonmalignant renal disease", " Cardiovascular:", " No serious nonmalignant cardiovascular disease", " Pulmonary:", " No serious nonmalignant pulmonary disease", " Other:", " Not pregnant or nursing", " Fertile patients must use effective contraception", " No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy", " No other malignancy except:", " Nonmelanomatous skin cancer", " Carcinoma in situ of the cervix or endometrium", " Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)", " Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation", " No psychiatric or addictive disorder that would preclude informed consent or study compliance", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " Not specified", " Chemotherapy:", " See Disease Characteristics", " Concurrent standard adjuvant chemotherapy allowed", " Endocrine therapy:", " See Disease Characteristics", " Concurrent standard adjuvant hormonal therapy allowed", " Radiotherapy:", " See Disease Characteristics", " Surgery:", " See Disease Characteristics" ]

[ "INTERVENTION 1: ", " Letrozole", " Letrozole 2.5 mg/day for 3 years", "INTERVENTION 2: ", " Letrozole + Zoledronic Acid", " Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months" ]

[ "INTERVENTION 1: ", " Tamoxifen", " Tamoxifen 20mg orally daily for 5 years", "INTERVENTION 2: ", " Ovarian Function Suppression", " Tamoxifen 20mg orally daily or Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)", " Note: Data were collected separately for the T+OFS and E+OFS participants in the parent study, IBCSG 24-02 (SOFT). The sample size for this Co-SOFT substudy was small, so the analysis plan was revised to pre-specify collective analysis for all patients receiving OFS." ]

[ "Outcome Measurement: ", " Centrally Assessed Progression Free Survival", " Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.", " Time frame: From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.", "Results 1: ", " Arm/Group Title: Neratinib Plus Capecitabine", " Arm/Group Description: neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.", " Overall Number of Participants Analyzed: 307", " Mean (95% Confidence Interval)", " Unit of Measure: months 8.8 (7.8 to 9.8)", "Results 2: ", " Arm/Group Title: Lapatinib Plus Capecitabine", " Arm/Group Description: lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.", " Overall Number of Participants Analyzed: 314", " Mean (95% Confidence Interval)", " Unit of Measure: months 6.6 (5.9 to 7.4)" ]

[ "Outcome Measurement: ", " Overall Survival (OS)", " OS was measured from the date of randomization until the date of death from any cause, or the last date the participant was known to be alive. Participants who were lost to follow-up or who were alive at the date of data cutoff were censored. The censoring rules for OS were as follows: 1) if the participant was still alive at data cutoff, the date of data cutoff was considered the end date, and 2) if the participant was lost to follow-up before data cutoff, the date they were last known to be alive was considered the end date. Participants who survived past the end of the study were counted as in the full study period. If death occurred after data cutoff, the end date was to be censored at the time of data cutoff.", " Time frame: From date of randomization until date of death from any cause, assessed up to data cutoff date of 12 Mar 2012, or up to approximately 6 years", "Results 1: ", " Arm/Group Title: Eribulin Mesylate 1.4 mg/m^2", " Arm/Group Description: Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.", " Overall Number of Participants Analyzed: 554", " Median (95% Confidence Interval)", " Unit of Measure: days 484 (462 to 536)", "Results 2: ", " Arm/Group Title: Capecitabine 2.5 g/m^2/Day", " Arm/Group Description: Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days.", " Overall Number of Participants Analyzed: 548", " Median (95% Confidence Interval)", " Unit of Measure: days 440 (400 to 487)" ]

[ "Outcome Measurement: ", " Percentage Change From Baseline in Urinary N-telopeptide of Type I Collagen (u-NTx) at Week 4", " u-NTx is a biochemical index of bone resorption. Participants provided urine specimens on Day 1 (baseline) and at Week 4 for measurement of u-NTx.", " Time frame: Baseline and Week 4", "Results 1: ", " Arm/Group Title: Single IV Infusion of ZA 4 mg", " Arm/Group Description: Participants received a single IV infusion of ZA 4 mg at the start of treatment and a once-daily odanacatib matching placebo tablet for 4 weeks.", " Overall Number of Participants Analyzed: 14", " Mean (95% Confidence Interval)", " Unit of Measure: Percentage change -73 (-80 to -62)", "Results 2: ", " Arm/Group Title: Once-daily Odanacatib 5 mg", " Arm/Group Description: Participants received a once-daily odanacatib 5 mg tablet for 4 weeks and a single IV infusion of ZA matching placebo at the start of treatment.", " Overall Number of Participants Analyzed: 27", " Mean (95% Confidence Interval)", " Unit of Measure: Percentage change -77 (-82 to -71)" ]

[ "Outcome Measurement: ", " Number of Participants With Treatment-Emergent Adverse Events (All Causalities)", " An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. All AEs reported after initiation of study drug treatment were considered as treatment emergent adverse events (TEAEs). AE severity was graded according to Common Terminology Criteria for AEs (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.", " Time frame: Baseline up to 28 days after last dose of study treatment, an average of 14 months", "Results 1: ", " Arm/Group Title: Palbociclib+Letrozole India Cohort", " Arm/Group Description: Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment ofr each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information", " Overall Number of Participants Analyzed: 100", " Measure Type: Count of Participants", " Unit of Measure: Participants Participants with adverse events: 92 92.0%", " Participants with serious adverse events: 18 18.0%", " Participants with grade 3 or 4 adverse events: 69 69.0%", " Participants with grade 5 adverse events: 3 3.0%", " Participants discontinued due to adverse events: 2 2.0%", "Results 2: ", " Arm/Group Title: Palbociclib+Letrozole Australia Cohort", " Arm/Group Description: Participants received Palbociclib orally once a day at 125 mg for 21 days followed by 7 days off treatment for each 28-day cycle. Participants received Letrozole orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information", " Overall Number of Participants Analyzed: 152", " Measure Type: Count of Participants", " Unit of Measure: Participants Participants with adverse events: 152 100.0%", " Participants with serious adverse events: 45 29.6%", " Participants with grade 3 or 4 adverse events: 124 81.6%", " Participants with grade 5 adverse events: 7 4.6%", " Participants discontinued due to adverse events: 9 5.9%" ]

[ "INTERVENTION 1: ", " Suramin and Paclitaxel", " Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin." ]

[ "INTERVENTION 1: ", " Ipatasertib and Paclitaxel", " Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.", "INTERVENTION 2: ", " Placebo and Paclitaxel", " Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination." ]

[ "Adverse Events 1:", " Total: 83/680 (12.21%)", " Hemoglobin 11/680 (1.62%)", " Transfusion: Platelets 0/680 (0.00%)", " Transfusion: pRBCs 0/680 (0.00%)", " Febrile neutropenia 49/680 (7.21%)", " Edema 1/680 (0.15%)", " Ischemia/infarction 0/680 (0.00%)", " Palpitations 0/680 (0.00%)", " Pericardial effusion 0/680 (0.00%)", " Keratitis 1/680 (0.15%)", " Double vision 1/680 (0.15%)", " Colitis 1/680 (0.15%)", "Adverse Events 2:", " Total: 86/688 (12.50%)", " Hemoglobin 15/688 (2.18%)", " Transfusion: Platelets 1/688 (0.15%)", " Transfusion: pRBCs 1/688 (0.15%)", " Febrile neutropenia 41/688 (5.96%)", " Edema 0/688 (0.00%)", " Ischemia/infarction 0/688 (0.00%)", " Palpitations 1/688 (0.15%)", " Pericardial effusion 1/688 (0.15%)", " Keratitis 0/688 (0.00%)", " Double vision 0/688 (0.00%)", " Colitis 0/688 (0.00%)" ]

[ "INTERVENTION 1: ", " GnRHa (Gonadotrophin-releasing Hormone Analogues) Group", " Eligible patients with breast cancer treated with GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy.", " Goserelin 3.6mg, or leuprorelin 3.75mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.", "INTERVENTION 2: ", " None GnRHa (Gonadotrophin-releasing Hormone Analogues) Group", " Eligible patients with breast cancer treated without GnRHa (Gonadotrophin-releasing Hormone Analogues) while receiving chemotherapy." ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.", " Time frame: From randomization to the earliest date of documentation of disease progression, up to 5 years", "Results 1: ", " Arm/Group Title: Arm A", " Arm/Group Description: Patients receive oral capecitabine twice daily on days 1-14 and oral lapatinib ditosylate once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. lapatinib ditosylate: Given PO and capecitabine: Given PO", " Overall Number of Participants Analyzed: 19", " Median (95% Confidence Interval)", " Unit of Measure: Median survival and CI in months 6.0 (4.3 to 8.6)", "Results 2: ", " Arm/Group Title: Arm B", " Arm/Group Description: Patients receive capecitabine and lapatinib ditosylate as in arm I. Patients also receive cixutumumab IV over 1-1 hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cixutumumab: Given IV, lapatinib ditosylate: Given PO and capecitabine: Given PO", " Overall Number of Participants Analyzed: 37", " Median (95% Confidence Interval)", " Unit of Measure: Median survival and CI in months 4.9 (2.9 to 8.5)" ]

[ "Adverse Events 1:", " Total: 12/63 (19.05%)", " Febrile neutropenia * [1]4/63 (6.35%)", " Congestive heart failure * [2]1/63 (1.59%)", " Cardiac-ischemia/infarction * 1/63 (1.59%)", " Vomiting * [1]1/63 (1.59%)", " Acute Pharyngitis * 1/63 (1.59%)", " Infection * 3/63 (4.76%)", " Neutrophil count decreased * [1]1/63 (1.59%)", " Pneumonitis/pulmonary infiltrates * [3]1/63 (1.59%)" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent imaging review (IIR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) calculated by Clopper-Pearson method. As planned, data up to the primary completion date only were analyzed.", " Time frame: From date of first dose of study drug administration to date of first documentation of disease progression or death, whichever occurred first (up to 3 years 11 months)", "Results 1: ", " Arm/Group Title: Stratum 1: Eribulin Mesylate + Pembrolizumab", " Arm/Group Description: Participants with mTNBC who were never treated with systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 1.", " Overall Number of Participants Analyzed: 66", " Measure Type: Number", " Unit of Measure: percentage of participant 25.8 (15.8 to 38.0)", "Results 2: ", " Arm/Group Title: Stratum 2: Eribulin Mesylate + Pembrolizumab", " Arm/Group Description: Participants with mTNBC previously treated with 1 to 2 lines of systemic anticancer therapy in the metastatic setting received eribulin mesylate 1.4 mg/m^2, intravenous infusion on Days 1 and 8 and pembrolizumab 200 mg, intravenous infusion on Day 1 in Treatment Cycle 1 (safety run-in, Phase 1b) and then continued in each 21-days Treatment Cycles in the presence of clinical benefit until confirmed disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor in Phase 2 in the Stratum 2.", " Overall Number of Participants Analyzed: 101", " Measure Type: Number", " Unit of Measure: percentage of participant 21.8 (14.2 to 31.1)" ]

[ "Adverse Events 1:", " Total: 10/41 (24.39%)", " Cardiac failure * 1/41 (2.44%)", " Pericardial effusion * 1/41 (2.44%)", " Ascites * 1/41 (2.44%)", " Diarrhoea * 0/41 (0.00%)", " Dysphagia * 0/41 (0.00%)", " Large intestinal obstruction * 0/41 (0.00%)", " Lung infection * 1/41 (2.44%)", " Pneumonia * 1/41 (2.44%)", " Sepsis * 1/41 (2.44%)", " Ejection fraction decreased * 2/41 (4.88%)", " Neck pain * 1/41 (2.44%)", "Adverse Events 2:", " Total: 8/37 (21.62%)", " Cardiac failure * 0/37 (0.00%)", " Pericardial effusion * 0/37 (0.00%)", " Ascites * 1/37 (2.70%)", " Diarrhoea * 1/37 (2.70%)", " Dysphagia * 1/37 (2.70%)", " Large intestinal obstruction * 1/37 (2.70%)", " Lung infection * 0/37 (0.00%)", " Pneumonia * 0/37 (0.00%)", " Sepsis * 0/37 (0.00%)", " Ejection fraction decreased * 0/37 (0.00%)", " Neck pain * 0/37 (0.00%)" ]

[ "Adverse Events 1:", " Total: 3/41 (7.32%)", " ANEMIA 1/41 (2.44%)", " FEBRILE NEUTROPENIA 1/41 (2.44%)", " LEUKOPENIA 1/41 (2.44%)", " NEUTROPENIA 2/41 (4.88%)", " THROMBOCYTOPENIA 2/41 (4.88%)", " DIARRHEA 1/41 (2.44%)", " DYSPEPSIA 1/41 (2.44%)", " FLATULENCE 1/41 (2.44%)", " MUCOSITIS 1/41 (2.44%)", " NAUSEA 2/41 (4.88%)", " VOMITING 2/41 (4.88%)", " EDEMA 1/41 (2.44%)", " FATIGUE 2/41 (4.88%)", " PHARYNGITIS 1/41 (2.44%)" ]

[ "Outcome Measurement: ", " Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.", " PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesions from baseline; Stable disease is neither sufficient shrinkage to qualify for a PR nor sufficient increase of lesions to qualify for Progressive disease (PD); Progressive Disease- is at least a 20% increase in the sum of diameters of target lesions from nadir.", " Time frame: From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C", "Results 1: ", " Arm/Group Title: Arm A: Nab-Paclitaxel + Gemcitabine", " Arm/Group Description: Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by intravenous (IV) administration followed by gemcitabine 1000 mg/m^2 on Days 1 and 8 by IV administration of each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment", " Overall Number of Participants Analyzed: 61", " Median (95% Confidence Interval)", " Unit of Measure: months 5.5 (4.1 to 7.0)", "Results 2: ", " Arm/Group Title: Arm B: Nab-Paclitaxel + Carboplatin", " Arm/Group Description: Participants received nab-Paclitaxel 125 mg/m^2 on Days 1 and 8 by IV administration followed by carboplatin area under the curve 2 (AUC 2) on Days 1 and 8 in each 21-day treatment cycle. Participants continued treatment until progressive disease (PD), unacceptable toxicity, required palliative radiotherapy or surgical intervention of lesion(s), withdrawal from study treatment, withdrawal of study consent, participant refusal or the investigator felt it was no longer in the best interest of the participant to continue on treatment.", " Overall Number of Participants Analyzed: 64", " Median (95% Confidence Interval)", " Unit of Measure: months 8.3 (5.7 to 10.6)" ]