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[ "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" ]

[ "Outcome Measurement: ", " Fraction of Patients With Increased Levels of Circulating Endothelial Cells", " An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).", " Time frame: After 3 weeks of treatment", "Results 1: ", " Arm/Group Title: Treatment (Cediranib Maleate)", " Arm/Group Description: Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 26", " Measure Type: Number", " Unit of Measure: percentage of participants 30" ]

[ "Outcome Measurement: ", " Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12", " Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.", " Time frame: 12 months", "Results 1: ", " Arm/Group Title: Denosumab 60 mg Q6M", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 123", " Least Squares Mean (95% Confidence Interval)", " Unit of Measure: Percent Change from Baseline 4.8 (4.3 to 5.4)", "Results 2: ", " Arm/Group Title: Placebo", " Arm/Group Description: [Not Specified]", " Overall Number of Participants Analyzed: 122", " Least Squares Mean (95% Confidence Interval)", " Unit of Measure: Percent Change from Baseline -.7 (-1.3 to -.1)" ]

[ "Inclusion Criteria:", " Histologically confirmed invasive adenocarcinoma of the breast.", " Primary palpable disease confined to the breast and axilla on physical examination (clinical Stage II or III disease). For patients without clinically suspicious axillary adenopathy, the primary must be >2 cm in diameter by physical examination or imaging studies (clinical T2-3, N0-2, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). Patients who have had axillary node dissection and have pN3a (i.e. 10 involved axillary nodes) are also eligible.", " Patients entering the trial after undergoing an axillary node dissection will be eligible if they meet other entry criteria.", " Estrogen receptor (ER) and progesterone receptor (PR) status in the primary tumor known or pending at the time of study registration.", " Resolution of all acute effects of surgical procedures to grade 1. For patients who had or will have, a sentinel node and/or axillary node dissection, completion at least 1 week prior to the initiation of study treatment with a well-healed wound is required.", " Bilateral, synchronous breast cancer is allowed if both primary tumors are HER2-negative and at least one meets the specified qualifying tumor or nodal inclusion criteria.", " Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.", " Patients entering this study must be willing to provide release of tumor tissue collected at baseline during a diagnostic procedure if available, and at the time of future surgical procedure(s) for correlative testing. If tissue is not available, the patient will still be eligible for enrollment to the study.", " No evidence of metastatic disease, as documented by complete staging workup 8 weeks prior to initiation of study treatment.", " No prior treatment for this breast cancer with the exception of criterion #3.", " HER2-negative tumor status defined as:", " Immunohistochemical (IHC) 0-1+ or", " IHC 2+ or IHC 3+ confirmed as FISH (Fluorescence in situ hybridization) or SISH (Silver in situ hybridization) negative (defined by ratio <2.2)", " Adequate hematologic function defined as:", " Absolute neutrophil count (ANC) 1500/μL", " Hemoglobin (Hgb) 10 g/dL", " Platelets 100,000/uL", " Adequate liver function defined as:", " Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x the upper limit of normal (ULN)", " Total bilirubin the institutional ULN", " Adequate renal function defined as:", " Serum creatinine 1.5 mg/dL x ULN OR calculated creatinine clearance 50 mL/min by the Cockcroft-Gault method:", " GRF =(140-age) x (weight/kg) x (0.85 if female) (72 x serum creatinine mg/dL)", " Other laboratory testing:", " Serum magnesium the institutional lower limit of normal (LLN)", " Serum potassium the institutional LLN", " Female and 18 years of age.", " Negative serum pregnancy test within <7 days prior to initial trial treatment.", " Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures that are approved by their study physician while receiving study treatment and continuing for 3 weeks after the last dose of study drug treatment, who are not breastfeeding, and who have a negative serum pregnancy test prior to start of dosing.", " Willingness and ability to comply with trial and follow-up procedures.", " Ability to understand the nature of this trial and give written informed consent.", "Exclusion Criteria:", " Clinical T4 lesions, including inflammatory breast cancer. Clinical N3 involvement (e.g., ipsilateral, infraclavicular, supraclavicular, and internal mammary nodes).", " Peripheral neuropathy (motor or sensory) > grade 1 according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).", " Patient has received radiotherapy for treatment of previous cancer that included 30% of major bone marrow containing areas (e.g., pelvis, lumbar, spine).", " Known or suspected allergy or hypersensitivity to any of the study drugs (i.e., eribulin, cyclophosphamide, docetaxel) or known hypersensitivity to polysorbate 80.", " Patients with acute or chronic liver or renal disease or pancreatitis.", " Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).", " Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment. However, use of GNRH agonists for the purpose of fertility preservation or suppression of heavy menses is permitted (see Section 5.4.1).", " Patient has any of the following cardiac diseases currently or within the last 6 months:", " Left Ventricular Ejection Fraction (LVEF) <45% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)", " Heart rate-corrected QT interval (QTc) > 480 ms on screening electrocardiogram (ECG) (using Bazett's formula)", " Unstable angina pectoris", " Congestive heart failure (New York Heart Association [NYHA] Grade 2", " Acute myocardial infarction", " Conduction abnormality not controlled with pacemaker or medication", " Significant ventricular or supraventricular arrhythmias (Patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).", " Valvular disease with significant compromise in cardiac function", " Chronic use of drugs that cause QTc prolongation. Patients must discontinue use of these drugs 7 days prior to the start of study treatment.", " Presence of other active cancers, or history of treatment for invasive cancer 5 years. Patients with stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.", " Patients may not receive any other investigational or anti-cancer treatments while participating in this trial.", " Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.", " Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol." ]

[ "Adverse Events 1:", " Total: 4/36 (11.11%)", " Rectal hemorrhage * 1/36 (2.78%)", " Disease progression * 1/36 (2.78%)", " Device related infection * 1/36 (2.78%)", " Skin infection * 1/36 (2.78%)", " Hypotension * 1/36 (2.78%)" ]

[ "Adverse Events 1:", " Total: 15/41 (36.59%)", " Febrile neutropenia * 0/41 (0.00%)", " Diarrhea * 1/41 (2.44%)", " Stomach pain * 1/41 (2.44%)", " Fever * 2/41 (4.88%)", " Cytokine release syndrome * 1/41 (2.44%)", " Infection * 1/41 (2.44%)", " Skin infection * 2/41 (4.88%)", " Urinary tract infection * 1/41 (2.44%)", " Coagulopathy * 0/41 (0.00%)", " INR increased * 0/41 (0.00%)", " Lipase increased * 1/41 (2.44%)", "Adverse Events 2:", " Total: 2/5 (40.00%)", " Febrile neutropenia * 1/5 (20.00%)", " Diarrhea * 0/5 (0.00%)", " Stomach pain * 0/5 (0.00%)", " Fever * 0/5 (0.00%)", " Cytokine release syndrome * 0/5 (0.00%)", " Infection * 0/5 (0.00%)", " Skin infection * 0/5 (0.00%)", " Urinary tract infection * 0/5 (0.00%)", " Coagulopathy * 1/5 (20.00%)", " INR increased * 1/5 (20.00%)", " Lipase increased * 0/5 (0.00%)" ]

[ "Inclusion Criteria:", " Post-menopausal women at high risk for development of breast cancer", " On a stable dose of hormone replacement therapy", " have cytomorphologic evidence of hyperplasia +/- atypia and Ki-67 expression >1.5% in benign breast epithelial cells acquired by RPFNA", " Serum level of 25-OH vitamin D of at least 30 ng/ml prior to study entry", " Willing to have a repeat random periareolar fine needle aspiration (RPFNA) and mammogram at 6 months and 12 months (if participating in the open label portion of the study) following initiation of study drug", "Exclusion Criteria:", " Prior history of osteoporosis or osteoporotic fracture.", " Prior history of invasive breast cancer or other invasive cancer within five years from date of study entry.", " Current and chronic use of cyclooxygenase-2 (COX-2) specific inhibitors or NSAIDs", " Receiving treatment for rheumatoid arthritis or fibromyalgia", " Current history of poorly controlled migraines or perimenopausal symptoms", " Currently receiving other investigational agents.", " Receipt of more than 6 months of an aromatase inhibitor (anastrozole, exemestane, letrozole, etc.) at any time in the past." ]

[ "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: 2/81 (2.47%)", " Heart failure 0/81 (0.00%)", " Fever 1/81 (1.23%)", " Cold 0/81 (0.00%)", " Catheter related infection (Bacteriemia) 0/81 (0.00%)", " Lack of strength in left leg 0/81 (0.00%)", " Ostenecrosis produced by biphosphonates 0/81 (0.00%)", " Gastric cancer 0/81 (0.00%)", " Stroke 0/81 (0.00%)", " Hematuria 1/81 (1.23%)", " Nodule in left breast 0/81 (0.00%)", "Adverse Events 2:", " Total: 10/85 (11.76%)", " Heart failure 1/85 (1.18%)", " Fever 0/85 (0.00%)", " Cold 1/85 (1.18%)", " Catheter related infection (Bacteriemia) 1/85 (1.18%)", " Lack of strength in left leg 1/85 (1.18%)", " Ostenecrosis produced by biphosphonates 1/85 (1.18%)", " Gastric cancer 1/85 (1.18%)", " Stroke 1/85 (1.18%)", " Hematuria 0/85 (0.00%)", " Nodule in left breast 1/85 (1.18%)" ]

[ "Outcome Measurement: ", " Clinical Benefit Response (Independent Reviewer-assessed)", " CBR is defined as the percentage of participants receiving at least one dose of study medication who achieved a best overall response classified as a complete or partial (confirmed) tumor response or stable disease for at least 6 months (24 weeks). A \"complete response\" is defined as the disappearance of all target or non-target lesions, \"partial response\" and \"disease progression\" as at least a 30% decrease and at least a 20% increase, respectively, in the sum of the longest diameter of target lesions, and \"stable disease\" as neither \"partial response\" nor \"disease progression.\"", " Time frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119)", "Results 1: ", " Arm/Group Title: Lapatinib 1250 mg and Capecitabine 2000 mg/m^2", " Arm/Group Description: Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: percentage of participants 59" ]

[ "INTERVENTION 1: ", " Arm I", " Patients receive ONTAK IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.", " ONTAK: Given IV", " flow cytometry: Correlative studies", " immunohistochemistry staining method: Correlative studies", " enzyme-linked immunosorbent assay: Correlative studies", " laboratory biomarker analysis: Correlative studies", " protein expression analysis: Correlative studies" ]

[ "Inclusion Criteria:", " HER2-positive disease determined locally", " Histologically or cytologically confirmed invasive breast cancer", " Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent", " Documented progression of incurable, unresectable, LABC, or mBC, defined by the investigator: progression must occur during or after most recent treatment for LABC/mBC or within 6 months of completing adjuvant therapy", " Measurable and/or non-measurable disease", " Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)", " Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2", " Adequate organ function", " Use of highly effective contraception as defined by the protocol", "Exclusion Criteria:", " History of treatment with trastuzumab emtansine", " Prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not", " Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v 4.0", " History of other malignancy within the previous 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", " History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria", " History of exposure to cumulative doses of anthracyclines", " History of radiation therapy within 14 days of first study treatment. The participant must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.", " Metastatic central nervous system (CNS) disease only", " Brain metastases which are symptomatic", " History of a decrease in LVEF to less than (<) 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment", " History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment", " History of myocardial infarction or unstable angina within 6 months of first study treatment", " Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy", " Current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease)", " Pregnancy or lactation", " Currently known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus", " History of intolerance (such as Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product" ]

[ "INTERVENTION 1: ", " Stage 1 Clinical Management", " The group will receive clinical management treatment only each session.", " Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.", " Following are major elements:", " Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.", "INTERVENTION 2: ", " Stage 1 CBT", " The experimental group will receive CBT each session.", " CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention." ]

[ "INTERVENTION 1: ", " Neratinib 240, Prior Trastuzumab", " Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.", "INTERVENTION 2: ", " Neratinib 240, No Prior Trastuzumab", " Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment." ]

[ "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)" ]

[ "Adverse Events 1:", " Total: 0/161 (0.00%)", " Gastrointestinal-Other 0/161 (0.00%)", " Dehydration 0/161 (0.00%)", " Renal/Genitourinary-Other 0/161 (0.00%)", "Adverse Events 2:", " Total: 1/64 (1.56%)", " Gastrointestinal-Other 1/64 (1.56%)", " Dehydration 1/64 (1.56%)", " Renal/Genitourinary-Other 1/64 (1.56%)" ]

[ "Adverse Events 1:", " Total: 13/34 (38.24%)", " Anemia 3/34 (8.82%)", " Diarrhea 7/34 (20.59%)", " Nausea 2/34 (5.88%)", " Sepsis 1/34 (2.94%)", " Urinary tract infection 1/34 (2.94%)", " Alkaline phosphatase increased 1/34 (2.94%)", " Neutrophil count decreased 2/34 (5.88%)", " Dehydration 1/34 (2.94%)", " Headache 1/34 (2.94%)", " Thromboembolic event 1/34 (2.94%)" ]

[ "INTERVENTION 1: ", " Adjuvant Radiotherapy", " Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.", " Adjuvant Radiotherapy: Adjuvant radiation therapy" ]

[ "INTERVENTION 1: ", " Hypnotherapy", " Patients randomized to the hypnosis arm of the study will undergo individually three one-hour sessions with a certified hypnotherapist. These sessions will be one week apart. Patients will also be instructed on the use of self-hypnosis techniques to use at home.", "INTERVENTION 2: ", " Gabapentin", " Patients randomized to the gabapentin arm will be prescribed 900mg of the drug daily (300 mg by mouth three times daily)." ]

[ "Inclusion Criteria:", " Completely resected (greater or equal 1mm), histologically or cytologically proven unilateral breast cancer", " Female greater or equal 18 years of age", " If (neo) adjuvant chemotherapy received, patient must have received at least 4 cycles. Chemotherapy must be completed prior to study entry", " Hormone Receptor negatives must have received prior chemotherapy", " Study entry must be within any of the following timelines: 3 months of the end of definitive breast surgery OR between 3 weeks and 4 months after day 1 of the last cycle of adjuvant chemotherapy OR 6 weeks of the end of radiotherapy.", " WHO performance status 0 or 1", " Pre-treatment haematology and biochemistry values within acceptable local limits: Haemoglobin, white blood cell greater or equal to 3.0 x 109/l or absolute neutrophil count greater or equal to 1.51 x 109/l, Platelets greater or equal to 100 x 109/l, Serum bilirubin less than 1.5 x upper normal limit , Alkaline phosphatase less or equal to 1.5 x upper normal limit , Serum creatinine less than 1.5 x upper normal limit", " Negative pregnancy test for patients with child-bearing potential", " Normal baseline ECG and clinical cardiovascular assessment after completion of all (neo) adjuvant chemotherapy", " No previous or current evidence for metastatic disease", " Be accessible for and consent to long term follow-up", " Written informed consent prior to commencement of specific protocol procedures must be obtained and documented according to the local regulatory requirements", " Exclusion Criteria", " Patients with node negative, T1, Grade 1 breast cancer", " Unresectable, metastatic or bilateral breast cancer", " Active or previous peptic ulceration or gastrointestinal bleeding in the last year", " Active or previous history of inflammatory bowel disease", " A past history of adverse reaction/hypersensitivity to NSAIDs, including celecoxib and salicylates, or sulphonamides", " On current or planned chronic NSAIDs therapy (except low dose aspirin 100 mg four times per day or 325mg once daily).", " Current or long-term use of oral corticosteroids", " Known or suspected congestive heart failure (greater than New York Heart Association I) and/or coronary heart disease, previous history of myocardial infarction, uncontrolled arterial hypertension (ie BP greater than 160/90mmHg) under treatment with two anti-hypertensive drugs, rhythm abnormalities requiring permanent treatment.", " Patients with diabetes controlled by diet and oral medication are eligible for the study however patients with insulin dependent diabetes are excluded", " Past history of stroke/Transient ischaemic attack, symptomatic peripheral vascular disease or carotid disease", " Previously entered into an adjuvant chemotherapy trial for which approval for entry into REACT has not been granted", " ER receptor status unknown, Human epidermal growth factor receptor 2 or FISH positive, or Human epidermal growth factor receptor 2 status unknown", " 14. Hormone Receptor negative and not received (neo)adjuvant chemotherapy 15. Use of hormone replacement therapy within the last 6 weeks 16. Pregnant or lactating women or women of childbearing potential unwilling/unable to use non-hormonal contraception 17. No previous or concomitant malignancies except adequately treated squamous cell / basal cell carcinoma of the skin, in situ carcinoma of the cervix or ductal carcinoma in situ/lobular carcinoma in situ of the breast, unless there has been a disease-free interval of 10 years or more 18. Psychiatric or addictive disorders which could preclude obtaining informed consent 19. Clinical evidence of severe osteoporosis and/or history of osteoporotic fracture" ]

[ "Outcome Measurement: ", " Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy", " Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).", " Time frame: 21 days (Cycle 1 of chemotherapy treatment)", "Results 1: ", " Arm/Group Title: LA-EP2006", " Arm/Group Description: During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.", " LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.", " Overall Number of Participants Analyzed: 155", " Mean (Standard Deviation)", " Unit of Measure: days FAS: 151 participants", " 1.36 (1.133)", " PP: 148 participants", " 1.34 (1.141)", "Results 2: ", " Arm/Group Title: Neulasta ", " Arm/Group Description: During each chemotherapy cycle eligible patients receive Neulasta s.c. post chemotherapy application.", " Neulasta : Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.", " Overall Number of Participants Analyzed: 153", " Mean (Standard Deviation)", " Unit of Measure: days FAS: 149 participants", " 1.19 (0.984)", " PP: 144 participants", " 1.19 (0.991)" ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. Kaplan-Meier survival curves will be used. A 95% confidence interval for the median PFS will be calculated. A lower bound greater than 8 months would be strong evidence that Nab-Paclitaxel- bevacizumab induction therapy followed by bevacizumab-erlotinib hydrochloride maintenance therapy is superior to paclitaxel and bevacizumab. However, a median PFS of 13 months or greater (regardless of whether the 95% confidence interval for the median extends below 8 months) could also indicate promising results.", " Time frame: Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 8 years", "Results 1: ", " Arm/Group Title: Tx (Chemo, MoAb, and Enzyme Inhibitor)", " Arm/Group Description: INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.", " MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity.", " paclitaxel albumin-stabilized nanoparticle formulation: Given IV", " bevacizumab: Given IV", " erlotinib hydrochloride: Given PO", " Overall Number of Participants Analyzed: 55", " Median (95% Confidence Interval)", " Unit of Measure: Months 9.1 (7.2 to 11.1)" ]

[ "Outcome Measurement: ", " Central Nervous System (CNS) Progression-free Survival(PFS)", " The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as <25% increase in tumor area.", " PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.", " Time frame: 3 months after treatment", "Results 1: ", " Arm/Group Title: Epothilone B: Group A", " Arm/Group Description: Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.", " Overall Number of Participants Analyzed: 45", " Measure Type: Number", " Unit of Measure: participants 12", "Results 2: ", " Arm/Group Title: Epothilone B: Group B", " Arm/Group Description: Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.", " Overall Number of Participants Analyzed: 10", " Measure Type: Number", " Unit of Measure: participants 2" ]

[ "Outcome Measurement: ", " Progression Free Survival", " Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.", " Time frame: From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)", "Results 1: ", " Arm/Group Title: Standard of Care (SOC)", " Arm/Group Description: Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.", " Overall Number of Participants Analyzed: 1048", " Median (95% Confidence Interval)", " Unit of Measure: Months 7.4 (7.1 to 7.6)", "Results 2: ", " Arm/Group Title: Epoetin Alfa", " Arm/Group Description: Participants received SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.", " Overall Number of Participants Analyzed: 1050", " Median (95% Confidence Interval)", " Unit of Measure: Months 7.4 (6.9 to 7.6)" ]

[ "Adverse Events 1:", " Total: 58/305 (19.02%)", " FEBRILE NEUTROPENIA * 12/305 (3.93%)", " NEUTROPENIA * 4/305 (1.31%)", " ANAEMIA * 2/305 (0.66%)", " LEUKOPENIA * 1/305 (0.33%)", " PANCYTOPENIA * 1/305 (0.33%)", " THROMBOCYTOPENIA * 1/305 (0.33%)", " DISSEMINATED INTRAVASCULAR COAGULATION * 0/305 (0.00%)", " ATRIAL FIBRILLATION * 1/305 (0.33%)", " DIASTOLIC DYSFUNCTION * 1/305 (0.33%)", " PERICARDIAL EFFUSION * 1/305 (0.33%)", "Adverse Events 2:", " Total: 50/304 (16.45%)", " FEBRILE NEUTROPENIA * 12/304 (3.95%)", " NEUTROPENIA * 1/304 (0.33%)", " ANAEMIA * 0/304 (0.00%)", " LEUKOPENIA * 0/304 (0.00%)", " PANCYTOPENIA * 0/304 (0.00%)", " THROMBOCYTOPENIA * 0/304 (0.00%)", " DISSEMINATED INTRAVASCULAR COAGULATION * 1/304 (0.33%)", " ATRIAL FIBRILLATION * 1/304 (0.33%)", " DIASTOLIC DYSFUNCTION * 0/304 (0.00%)", " PERICARDIAL EFFUSION * 0/304 (0.00%)" ]

[ "Adverse Events 1:", " Total: 31/52 (59.62%)", " Febrile neutropenia 2/52 (3.85%)", " Left ventricular dysfunction 2/52 (3.85%)", " Sinus tachycardia 1/52 (1.92%)", " Congenital arterial malformation 1/52 (1.92%)", " Diarrhoea 5/52 (9.62%)", " Salivary hypersecretion 1/52 (1.92%)", " Enteritis 1/52 (1.92%)", " Abdominal pain 1/52 (1.92%)", " Vomiting 1/52 (1.92%)", " Stomatitis 1/52 (1.92%)", " Haematemesis 1/52 (1.92%)" ]

[ "Inclusion Criteria:", " To be included in this study, you must meet the following criteria:", " Metastatic breast cancer confirmed by biopsy", " No more than one prior chemotherapy regimen for metastatic breast cancer", " Able to perform activities of daily living with minimal assistance", " Adequate bone marrow, liver and kidney function", " Age 18 years or older", " Give written informed consent", "Exclusion Criteria:", " You cannot participate in this study if any of the following apply to you:", " Moderate to severe peripheral neuropathy", " Uncontrolled blood pressure or uncontrolled heart beat irregularities", " Diabetes Mellitus with fasting blood sugar greater than 200 mg %", " Significant heart disease within the prior 6 months", " Severe or uncontrolled medical disease", " Active uncontrolled infection", " Known chronic liver disease", " Known diagnosis of HIV infection", " Pregnant or breast feeding females", " Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have." ]

[ "Eligibility Criteria:", " Patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.", " Patients must meet one of the criteria defined below (indicate one):", " a .Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment.", " b. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.", " Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.", " Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. Patients with hypertension or age > 60 years must have a Multiple Gated Acquisition (MUGA) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (NA) if no MUGA required) and Left Ventricular Ejection Fraction (LVEF) % must be greater than the institutional lower limit of normal.", " Patients must have a serum creatinine and bilirubin the institutional upper limit of normal, and an Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.", " Patients must have an Absolute neutrophil count (ANC) of 1,500/μl and a platelet count of 100,000/μl. These tests must have been performed within 90 days prior to registration.", " Patients must have a performance status of 0-2 by Zubrod criteria", " Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.", " All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines." ]

[ "Inclusion Criteria:", " Patients with a diagnosis of invasive adenocarcinoma of the breast confirmed by histology or cytology at MSKCC.", " Clinical evidence of metastatic breast cancer.", " HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH ( 2.0).", " Progressive disease following treatment with trastuzumab for metastatic breast cancer or as adjuvant therapy (either single-agent or combination therapy)", " Prior therapy inclusion:", " No more than two prior chemotherapy regimens allowed for advanced stage disease", " No prior fluoropyrimidine in the metastatic setting. Adjuvant fluoropyrimidine is permitted if >6 months prior to treatment on study.", " No restriction for prior hormonal therapy. No concurrent use of endocrine therapy is permitted.", " No more than 450mg/m2 cumulative dose of prior doxorubicin", " At least 3 weeks since prior chemotherapy or radiation therapy", " Age or = to 18. Because no dosing or adverse event data are currently available on the use of lapatinib in patients <18 years of age, children are excluded from this study.", " Patients must be willing to discontinue sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.", " Negative HCG pregnancy test for premenopausal women of reproductive capacity and for women less than 12 months after the menopause.", " Asymptomatic, central nervous system metastases are permitted if patients remain clinically stable after discontinuation of corticosteroids and anticonvulsants.", " ECOG performance status < or = to 2", " Life expectancy of greater than 12 weeks", " Patients must have normal organ and marrow function as defined below:", " leukocytes or = to 3,000/μL", " absolute neutrophil count or = 1,500/μL", " platelets or = 100,000/μL", " total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT) or = 2.5x institutional upper limit of normal serum creatinine within normal institutional limits", " Cardiac ejection fraction at or above the lower limit of normal of 50% as measured by multigated radionuclide angiography (MUGA) scan. If LVEF is greater than 70%, and ECHO should be performed as well. Baseline and on treatment scans should be performed using the same modality and preferably at the same institution.", " Ability to understand and the willingness to sign a written informed. consent document.", " Able to swallow and retain oral medication.", "Exclusion Criteria:", " Patients may not be receiving any concurrent anticancer therapy or investigational agents with the intention of treating breast cancer.", " History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or capecitabine.", " Known DPD deficiency.", " Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months of study entry, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.", " Pregnant women are excluded from this study because lapatinib is member of the 4- anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib.", " HIV-positive patients 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.", " Patients with 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).", " Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors:", " Medications that inhibit or induce CYP3A4 are prohibited. Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator.", " Renal function as measured by creatinine clearance < 30ml/min", " Patients are permitted to participate in other non-therapeutic clinical trials while receiving treatment on this study (ie, experimental imaging, minor procedures necessary for tissue acquisition on study)" ]

[ "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" ]

[ "Inclusion Criteria:", " female participants, age >/=18 years", " advanced, inflammatory or early stage unilateral invasive breast cancer", " HER2-positive breast cancer", " baseline left ventricular ejection fraction (LVEF) >/=55%", "Exclusion Criteria:", " metastatic disease (Stage IV) or bilateral breast cancer", " previous anticancer therapy or radiotherapy for any malignancy", " other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma", " clinically relevant cardiovascular disease", " current chronic treatment with corticosteroids of >10mg methylprednisolone or equivalent" ]

[ "Adverse Events 1:", " Total: 5/14 (35.71%)", " Ileus 1/14 (7.14%)", " General disorders and administration site conditions - Other, disease progression 2/14 (14.29%)", " Infections and infestations - Other, pneumonia 1/14 (7.14%)", " Acute kidney injury 1/14 (7.14%)" ]

[ "Adverse Events 1:", " Total: 3/9 (33.33%)", " Fatigue * 1/9 (11.11%)", " Non-cardiac chest pain * 1/9 (11.11%)", " Sepsis * 1/9 (11.11%)", " Urinary tract infection * 1/9 (11.11%)", " Syncope * 1/9 (11.11%)", " Anxiety * 1/9 (11.11%)", " Thromboembolic event * 1/9 (11.11%)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS)", " Time from date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS = (first event date minus randomization date +1) divided by 30.4", " Time frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death", "Results 1: ", " Arm/Group Title: Sunitinib + Paclitaxel", " Arm/Group Description: Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.", " Overall Number of Participants Analyzed: 242", " Median (95% Confidence Interval)", " Unit of Measure: Months 7.4 (6.9 to 8.5)", "Results 2: ", " Arm/Group Title: Bevacizumab + Paclitaxel", " Arm/Group Description: Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.", " Overall Number of Participants Analyzed: 243", " Median (95% Confidence Interval)", " Unit of Measure: Months 9.2 (7.7 to 13.0)" ]

[ "INTERVENTION 1: ", " Cholecalciferol", " Enrolled women received 50,000 IUs weekly supplementation of cholecalciferol for 8 weeks.", "INTERVENTION 2: ", " No Cholecalciferol", " Enrolled women with serum 25 (OH)D greater than or equal to 30 ng/ml received no intervention." ]

[ "Adverse Events 1:", " Total: 11/56 (19.64%)", " Febrile Neutropenia * 3/56 (5.36%)", " Neutropenia * 1/56 (1.79%)", " Pancytopenia * 1/56 (1.79%)", " Atrial Fibrillation * 1/56 (1.79%)", " Coronary Artery Disease * 1/56 (1.79%)", " Constipation * 1/56 (1.79%)", " Chest Pain * 1/56 (1.79%)", " Non-Cardiac Chest Pain * 1/56 (1.79%)", " Edema due to Cardiac Disease * 1/56 (1.79%)", " Cellulitis * 1/56 (1.79%)" ]

[ "INTERVENTION 1: ", " Arm I (Minocycline Hydrochloride)", " Patients receive minocycline hydrochloride PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.", "INTERVENTION 2: ", " Arm II (Placebo)", " Patients receive a placebo PO BID on days 1-7. Treatment repeats every 7 days for up to 12 courses in the absence of disease progression or unacceptable toxicity." ]

[ "INTERVENTION 1: ", " SCPR Intervention", " Young breast cancer participants will receive their SCPR and access to additional web-based educational reproductive health information, including resource lists of helpful websites, followed by regular reproductive health prompts and study adherence reminders for 24 weeks.", " Reproductive Health Survivorship Care Plan (SCPR): The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence", "INTERVENTION 2: ", " Control", " Young breast cancer participants randomized to the waitlist control arm will receive access to the web-based resources and study adherence reminders. At completion of the 24 weeks of follow up, they will have access to their SCPR.", " Control: Web-based resource lists and text-based study adherence reminders" ]

[ "INTERVENTION 1: ", " Arm 1: CsA", " Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).", " Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.", "Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14", " Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.", " Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).", "INTERVENTION 2: ", " Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2", " Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).", " Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.", "Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14", " Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.", " Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).", "Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9." ]

[ "Inclusion Criteria:", " Histologically confirmed diagnosis of invasive triple negative breast cancer", " Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening", " Candidates for mastectomy or breast-conserving surgery", " Primary tumor of greater than 20 mm and less than or equal to 50 mm diameter measured by imaging (previous Amendment #3 was tumor size greater than 10 mm)", " Regional nodes N0-N2", " Absence of distant metastatic disease", " ECOG performance status 0-1", " Adequate bone marrow function", " Adequate liver function and serum transaminases", " Adequate renal function", "Exclusion Criteria:", " Bilateral or inflammatory breast cancer (bilateral mammography is required during Screening/baseline); locally recurrent breast cancer", " Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months", " Uncontrolled cardiac disease", " Patients who are currently receiving chronic treatment (>3 months) with corticosteroids at a dose 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug", " Impaired GI function that may affect the absorption of LCL161", " Pregnant or breast feeding (lactating) women", " Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 180 days after study treatment", " Other protocol-defined inclusion/exclusion criteria may apply" ]

[ "Inclusion Criteria:", " Invasive breast cancer verified in a histological biopsy", " Age 65 or younger", " Estrogen receptor (ER), PgR and HER2 expression have been determined", " No distant metastases present (M0)", " The patient provides a written informed consent for study participation", " The estimated risk of breast cancer recurrence is high (25% or higher within the first 5 years from the date of the diagnosis, over >35% within the first 10 years from the diagnosis)", "Exclusion Criteria:", " Patients with breast cancer with \"a special histological type\" (mucinous, papillary, medullary, or tubular type of breast cancer) when no metastases are present in the ipsilateral axillary lymph nodes", " The WHO performance status is moderate/poor, Z >1", " The peripheral blood leukocyte count is less than 3.0 x 109/L, the blood granulocyte count is less than 1.5 x 109/L, or the blood thrombocyte count is less than 120 x 109/L", " Any physical or mental disorder that is considered to prohibit administration of chemotherapy", " Cardiac failure; severe cardiac arrythmia requiring regular medication" ]

[ "Inclusion Criteria:", " Females 18 years of age", " Histologically confirmed invasive breast cancer", " Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection", " Planning neoadjuvant chemotherapy", " HER2 positive disease", " Measurable disease in the breast after diagnostic biopsy, defined as longest diameter 2.0 cm", " Known estrogen receptor (ER) and progesterone receptor (PR) hormone receptor status at study entry", " Normal bone marrow function", " Normal hepatic function", " Normal renal function", " Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)-approved informed consent form before any study specific procedures", " Inclusion Criteria for Randomization:", " Left ventricular ejection fraction (LVEF) of 55% by 2D echocardiogram", " Complete all 4 cycles of run-in chemotherapy", "Exclusion Criteria:", " Bilateral breast cancer", " Presence of known metastases", " Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer", " Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix", " Pre-existing clinically significant ( grade 2) peripheral neuropathy", " Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension", " Severe dyspnea at rest requiring supplementary oxygen therapy", " History of positivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV)", " Recent infection requiring a course of systemic anti-infectives that were completed 14 days before enrollment (with the exception of uncomplicated urinary tract infection)", " Woman of childbearing potential who is pregnant or is breast feeding", " Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, true abstinence [periodic abstinence (eg calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of the protocol specified treatment", " Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study", " Other investigational procedures while participating in this study are excluded", " Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients", " Subject previously has enrolled and/or has been randomized in this study", " Subject likely to not be available to complete all protocol required study visits or procedures", " History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion" ]

[ "Outcome Measurement: ", " Clinical Benefit Defined as Complete Response (CR), Partial Response (PR) or Stable Disease (SD) Lasting >= 24 Weeks, as Determined by the Investigator According to RECIST v1.1", " Clinical Benefit was defined as CR, PR, or SD lasting more than equal to 24 weeks from randomization in participants with measurable disease at baseline, as determined by the investigator according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1. Per RECIST v1.1 for target lesions assessed by CT or MRI: CR, Disappearance of all target lesions; PR, PR >= 30% decrease in the sum of diameters of target lesions (TL) taking as reference the baseline sum of diameters; SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Disease Progression (PD), PD>= 20% increase in the sum of diameters of TL taking as reference the smallest sum on study(Nadir). In addition to the relative increase of 20% sum must have demonstrate an absolute increase of at least 5mm.", " Time frame: Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)", "Results 1: ", " Arm/Group Title: Venetoclax + Fulvestrant", " Arm/Group Description: Participants were administered Venetoclax 800mg orally QD and Fulvestrant 500mg IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: Percentage of Participants 11.8 (4.44 to 23.87)", "Results 2: ", " Arm/Group Title: Fulvestrant", " Arm/Group Description: Participants were administered Fulvestrant 500mg only IM on Day 1 and 15 of Cycle 1 and Day 1 of subsequent cycles (Cycle length = 28 days).", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: Percentage of Participants 13.7 (5.70 to 26.26)" ]

[ "INTERVENTION 1: ", " Samarium 153-EDTMP + Stem Cell Transplant", " Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP." ]

[ "INTERVENTION 1: ", " Exemestane", " Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.", "INTERVENTION 2: ", " Tamoxifen", " Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period." ]

[ "Inclusion Criteria:", " Histologically confirmed invasive adenocarcinoma of the breast.", " Primary palpable disease confined to the breast and axilla on physical examination (clinical Stage II or III disease). For patients without clinically suspicious axillary adenopathy, the primary must be >2 cm in diameter by physical examination or imaging studies (clinical T2-3, N0-2, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). Patients who have had axillary node dissection and have pN3a (i.e. 10 involved axillary nodes) are also eligible.", " Patients entering the trial after undergoing an axillary node dissection will be eligible if they meet other entry criteria.", " Estrogen receptor (ER) and progesterone receptor (PR) status in the primary tumor known or pending at the time of study registration.", " Resolution of all acute effects of surgical procedures to grade 1. For patients who had or will have, a sentinel node and/or axillary node dissection, completion at least 1 week prior to the initiation of study treatment with a well-healed wound is required.", " Bilateral, synchronous breast cancer is allowed if both primary tumors are HER2-negative and at least one meets the specified qualifying tumor or nodal inclusion criteria.", " Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.", " Patients entering this study must be willing to provide release of tumor tissue collected at baseline during a diagnostic procedure if available, and at the time of future surgical procedure(s) for correlative testing. If tissue is not available, the patient will still be eligible for enrollment to the study.", " No evidence of metastatic disease, as documented by complete staging workup 8 weeks prior to initiation of study treatment.", " No prior treatment for this breast cancer with the exception of criterion #3.", " HER2-negative tumor status defined as:", " Immunohistochemical (IHC) 0-1+ or", " IHC 2+ or IHC 3+ confirmed as FISH (Fluorescence in situ hybridization) or SISH (Silver in situ hybridization) negative (defined by ratio <2.2)", " Adequate hematologic function defined as:", " Absolute neutrophil count (ANC) 1500/μL", " Hemoglobin (Hgb) 10 g/dL", " Platelets 100,000/uL", " Adequate liver function defined as:", " Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x the upper limit of normal (ULN)", " Total bilirubin the institutional ULN", " Adequate renal function defined as:", " Serum creatinine 1.5 mg/dL x ULN OR calculated creatinine clearance 50 mL/min by the Cockcroft-Gault method:", " GRF =(140-age) x (weight/kg) x (0.85 if female) (72 x serum creatinine mg/dL)", " Other laboratory testing:", " Serum magnesium the institutional lower limit of normal (LLN)", " Serum potassium the institutional LLN", " Female and 18 years of age.", " Negative serum pregnancy test within <7 days prior to initial trial treatment.", " Female patients who are not of child-bearing potential, and female patients of child-bearing potential who agree to use adequate contraceptive measures that are approved by their study physician while receiving study treatment and continuing for 3 weeks after the last dose of study drug treatment, who are not breastfeeding, and who have a negative serum pregnancy test prior to start of dosing.", " Willingness and ability to comply with trial and follow-up procedures.", " Ability to understand the nature of this trial and give written informed consent.", "Exclusion Criteria:", " Clinical T4 lesions, including inflammatory breast cancer. Clinical N3 involvement (e.g., ipsilateral, infraclavicular, supraclavicular, and internal mammary nodes).", " Peripheral neuropathy (motor or sensory) > grade 1 according to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).", " Patient has received radiotherapy for treatment of previous cancer that included 30% of major bone marrow containing areas (e.g., pelvis, lumbar, spine).", " Known or suspected allergy or hypersensitivity to any of the study drugs (i.e., eribulin, cyclophosphamide, docetaxel) or known hypersensitivity to polysorbate 80.", " Patients with acute or chronic liver or renal disease or pancreatitis.", " Known diagnosis of human immunodeficiency virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).", " Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment. However, use of GNRH agonists for the purpose of fertility preservation or suppression of heavy menses is permitted (see Section 5.4.1).", " Patient has any of the following cardiac diseases currently or within the last 6 months:", " Left Ventricular Ejection Fraction (LVEF) <45% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)", " Heart rate-corrected QT interval (QTc) > 480 ms on screening electrocardiogram (ECG) (using Bazett's formula)", " Unstable angina pectoris", " Congestive heart failure (New York Heart Association [NYHA] Grade 2", " Acute myocardial infarction", " Conduction abnormality not controlled with pacemaker or medication", " Significant ventricular or supraventricular arrhythmias (Patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).", " Valvular disease with significant compromise in cardiac function", " Chronic use of drugs that cause QTc prolongation. Patients must discontinue use of these drugs 7 days prior to the start of study treatment.", " Presence of other active cancers, or history of treatment for invasive cancer 5 years. Patients with stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.", " Patients may not receive any other investigational or anti-cancer treatments while participating in this trial.", " Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.", " Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol." ]

[ "Inclusion Criteria:", " Adult Women ( 18 years old).", " Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.", " Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.", " HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).", " Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > 12 months prior to randomization.", " Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.", " Documentation of negative pregnancy test.", " Organ functions at time of inclusion.", "Exclusion Criteria:", " Prior mTOR inhibitors for the treatment of cancer.", " Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.", " Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).", " Radiotherapy to 25% of the bone marrow within 4 weeks prior to randomization", " History of central nervous system metastasis.", " Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.", " Serious peripheral neuropathy.", " Cardiac disease or dysfunction.", " Uncontrolled hypertension.", "HIV.", "Pregnant," ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 6/15 (40.00%)", " diarrhea and dehydration * 0/15 (0.00%)", " Severe Dehydration * 1/15 (6.67%)", " hypokalemia * 1/15 (6.67%)", " pain, swelling, mastectomy site cellulitis * 0/15 (0.00%)", " death progressive disease * 0/15 (0.00%)", " divetricular abscess * 0/15 (0.00%)", " fever * 1/15 (6.67%)", " febrile neutropenia * 3/15 (20.00%)", " Neutropenia * 0/15 (0.00%)", "Adverse Events 2:", " Total: 4/14 (28.57%)", " diarrhea and dehydration * 0/14 (0.00%)", " Severe Dehydration * 0/14 (0.00%)", " hypokalemia * 0/14 (0.00%)", " pain, swelling, mastectomy site cellulitis * 0/14 (0.00%)", " death progressive disease * 1/14 (7.14%)", " divetricular abscess * 0/14 (0.00%)", " fever * 0/14 (0.00%)", " febrile neutropenia * 2/14 (14.29%)", " Neutropenia * 0/14 (0.00%)" ]

[ "Adverse Events 1:", " Total: 116/396 (29.29%)", " Anaemia 3/396 (0.76%)", " Febrile neutropenia 20/396 (5.05%)", " Granulocytopenia 1/396 (0.25%)", " Leukopenia 1/396 (0.25%)", " Neutropenia 19/396 (4.80%)", " Atrial fibrillation 3/396 (0.76%)", " Cardiac failure congestive 0/396 (0.00%)", " Coronary artery disease 0/396 (0.00%)", " Left ventricular dysfunction 7/396 (1.77%)", " Myocardial infarction 3/396 (0.76%)", "Adverse Events 2:", " Total: 160/408 (39.22%)", " Anaemia 3/408 (0.74%)", " Febrile neutropenia 46/408 (11.27%)", " Granulocytopenia 0/408 (0.00%)", " Leukopenia 0/408 (0.00%)", " Neutropenia 18/408 (4.41%)", " Atrial fibrillation 0/408 (0.00%)", " Cardiac failure congestive 2/408 (0.49%)", " Coronary artery disease 1/408 (0.25%)", " Left ventricular dysfunction 6/408 (1.47%)", " Myocardial infarction 0/408 (0.00%)" ]

[ "Inclusion Criteria", " Ability to understand and the willingness to sign a written informed consent document.", " Histologic or cytologic diagnosis of adenocarcinoma originating in the breast.", " Evidence that the cancer is metastatic or locally advanced and not curable by local measures (i.e., surgery, radiation).", " NOTE: There is no limit on number of prior chemotherapy regimens received.", " Karnofsky performance status (KPS) score of 70 - 100; (Appendix 1).", " Life expectancy of at least 12 weeks.", " Adequate recovery of drug related toxicities from prior systemic therapy (recovery to < = Grade 1 except for Grade 2 fatigue and alopecia).", " Adequate recovery from recent surgery and radiation therapy. At least one week must have elapsed from the time of a minor surgery and/or focal/palliative radiation therapy; at least 3 weeks for major surgery and other radiation therapy.", " Women or Men, age > = 18 years.", " Patients must have normal organ and marrow function as defined below:", " Hematologic function with absolute neutrophils 1,500/mm3 and/or platelets > 125,000/mm3", " Hepatic function with serum bilirubin less than 1.5 times the upper institutional limits of normal, ALT 2.5 times the upper institutional limits of normal ( 5 times the upper institutional limits of normal if documented hepatic metastases are present)", " Renal function with serum creatinine 1.5 times the upper limit of normal", " Women of childbearing potential (WOCBP) and men with partners who are of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.", " WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea > = 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL). Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.", " - WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.", " Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.", " Exclusion Criteria", " Patients with known and active brain and/or leptomeningeal metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.", " CTC Grade 2 or greater neuropathy (motor or sensory) at study entry.", " Prior treatment with ixabepilone.", " Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.", " Known history of HIV infection.", " Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.", " Patients may not be receiving any other concurrent chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational.", " History of allergic reactions attributed to compounds of similar chemical or biologic composition to ixabepilone.", " Known prior severe hypersensitivity reactions to agents containing CremophorEL.", " Patients may not be receiving any prohibited therapies and/or medications.", " Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown." ]

[ "Inclusion Criteria:", " English or Spanish speaking women age 18", " Heart Rate > 60 bpm", " Systolic Blood Pressure > 100 mm/Hg", " Deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80mg/m2 or Abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of Adriamycin (60mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support.", " Echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) with ejection fraction > 50%.", " Patients with hormone receptor +/- and human epidermal growth factor receptor 2 protein (HER2) +/- breast cancer are eligible", " If a patient has HER2-positive breast cancer, Herceptin and Perjeta will be given along with taxane therapy", " Any stage invasive breast cancer provided the primary breast tumor size is 1 cm", " Agree to participate in research blood collection at 4 different time periods (20 ml = 4 teaspoons)", " Agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers. The biopsy prior to Taxol #1 is optional.", "Exclusion Criteria:", " Patients failing to meet the inclusion criteria", " Corrected QT interval (QTc) prolongation as defined by > 470 milliseconds on electrocardiogram (ECG)", " First-degree Atrioventricular (AV) block on ECG in which P-R interval lengthened > 200 milliseconds; Second Degree; or Third Degree", " On beta-blocker treatment. If discontinued, patients must have been off beta-blockers for at least 3 months.", " History of asthma, given concern for β-blockade in this population" ]

[ "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%)" ]

[ "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: 4/33 (12.12%)", " Diarrhea 1/33 (3.03%)", " Intracranial hemorrhage 1/33 (3.03%)", " Ischemia cerebrovascular 1/33 (3.03%)", " Confusion 1/33 (3.03%)", " Skin disorder 1/33 (3.03%)" ]

[ "Adverse Events 1:", " Total: 5/11 (45.45%)", " Nausea 1/11 (9.09%)", " Vomiting 1/11 (9.09%)", " Fever 1/11 (9.09%)", " skin infection [1]1/11 (9.09%)", " Hip fracture 0/11 (0.00%)", " Confusion 1/11 (9.09%)", "Adverse Events 2:", " Total: 1/12 (8.33%)", " Nausea 0/12 (0.00%)", " Vomiting 0/12 (0.00%)", " Fever 0/12 (0.00%)", " skin infection [1]0/12 (0.00%)", " Hip fracture 1/12 (8.33%)", " Confusion 0/12 (0.00%)" ]

[ "Adverse Events 1:", " Total: 5/11 (45.45%)", " Nausea 1/11 (9.09%)", " Vomiting 1/11 (9.09%)", " Fever 1/11 (9.09%)", " skin infection [1]1/11 (9.09%)", " Hip fracture 0/11 (0.00%)", " Confusion 1/11 (9.09%)", "Adverse Events 2:", " Total: 1/12 (8.33%)", " Nausea 0/12 (0.00%)", " Vomiting 0/12 (0.00%)", " Fever 0/12 (0.00%)", " skin infection [1]0/12 (0.00%)", " Hip fracture 1/12 (8.33%)", " Confusion 0/12 (0.00%)" ]

[ "Adverse Events 1:", " Total: 22/96 (22.92%)", " Anemia 1/96 (1.04%)", " Febrile neutropenia 4/96 (4.17%)", " Heart failure 1/96 (1.04%)", " Abdominal pain 1/96 (1.04%)", " Dysphagia 1/96 (1.04%)", " Mucositis oral 1/96 (1.04%)", " Nausea 1/96 (1.04%)", " Vomiting 2/96 (2.08%)", " Death NOS 0/96 (0.00%)", " Pain 1/96 (1.04%)", " Catheter related infection 1/96 (1.04%)", " Enterocolitis infectious 0/96 (0.00%)", "Adverse Events 2:", " Total: 3/60 (5.00%)", " Anemia 1/60 (1.67%)", " Febrile neutropenia 1/60 (1.67%)", " Heart failure 1/60 (1.67%)", " Abdominal pain 0/60 (0.00%)", " Dysphagia 0/60 (0.00%)", " Mucositis oral 0/60 (0.00%)", " Nausea 0/60 (0.00%)", " Vomiting 0/60 (0.00%)", " Death NOS 1/60 (1.67%)", " Pain 0/60 (0.00%)", " Catheter related infection 0/60 (0.00%)", " Enterocolitis infectious 1/60 (1.67%)" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " The ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Targeted lesions were assessed by computed tomography (CT) and magnetic resonance imaging (MRI) which were then assessed by the investigator based on RECIST. CR was defined as the disappearance of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters. Possible CR and PR had to be confirmed no fewer than 4 weeks after the initial response assessment. A brain and bone scan was performed by CT/MRI within 1 week after confirmation of a response to ensure no new metastases. To be assigned a status of CR or PR, changes in tumor measurements had to be confirmed by repeat evaluations, to be performed not fewer than 4 weeks after the response criteria were first met. ORR = CR + PR", " Time frame: Cycle 1 (Day 1) until first evidence of disease progression, assessed up to the data cutoff date (30 Aug 2013) up to 2.5 years", "Results 1: ", " Arm/Group Title: Eribulin Mesylate", " Arm/Group Description: Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.", " Overall Number of Participants Analyzed: 56", " Measure Type: Number", " Unit of Measure: Percentage of participants 28.6" ]

[ "Inclusion Criteria:", " Written informed consent.", " Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumors must be Human Epidermal Growth Factor Receptor 2 (HER2) negative. Patients must be free of disease in the axilla (node negative). If lymphadenectomy is done, at least 10 nodes must be examined. If sentinel node technique is used, sentinel node must be free of disease. Patients must present at least one high risk criterion (St. Gallen, 1998) as follows:", " Tumor size > 2 cm; and/or", " ER and Progesterone Receptor (PgR) negative; and/or", " Histological grade 2-3; and/or", " Age < 35 years old.", " Time window between surgery and study randomization must be less than 60 days.", " Surgery must consist of mastectomy or conservative surgery. Margins free of disease and ductal carcinoma in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.", " Patients must not present evidence of metastatic disease.", " Status of hormone receptors in primary tumor. Results must be available before the end of adjuvant chemotherapy.", " Status of HER2 in primary tumor, known before randomization. Patients with Immunohistochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescent in situ hybridization (FISH) is mandatory and result must be negative.", " Age >= 18 and <= 70 years old.", " Performance status (Karnofsky index) >= 80.", " Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).", " Laboratory results (within 14 days prior to randomization):", " Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100x 10^9/l; hemoglobin >= 10 mg/dl;", " Hepatic function: total bilirubin <= 1 upper normal limit (UNL); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of AST and ALT > 1.5 UNL are associated with alkaline phosphatase > 2.5 UNL, patient is not eligible.", " Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min.", " Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week time window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests, as clinically indicated.", " Patients able to comply with treatment and study follow-up.", " Negative pregnancy test done in the 14 previous days to randomization.", "Exclusion Criteria:", " Prior systemic therapy for breast cancer.", " Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.", " Prior radiotherapy for breast cancer.", " Bilateral invasive breast cancer.", " Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.", " Any T4 or N1-3 or M1 tumor.", " HER2 positive breast cancer (IHC 3+ or positive FISH result).", " Pre-existing grade >=2 motor or sensorial neurotoxicity by the National Cancer Institute Common Toxicity Criteria (NCICTC) v-2.0.", " Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.", " History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.", " Active uncontrolled infection.", " Active peptic ulcer; unstable diabetes mellitus.", " Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.", " Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.", " Concomitant treatment with other therapy for cancer.", "Males." ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed adenocarcinoma of the breast", " Stage III or IV disease", " Primary or recurrent disease", " Invasive lobular carcinoma allowed", " HLA-A1, -A2, -A3, or -A31 positive", " Underwent and recovered from prior primary therapy", " Patients with no clinical or radiological evidence of disease who had a previous diagnosis of stage III or IV breast cancer must have undergone prior antineoplastic therapy including, but not limited to, surgery, chemotherapy, and radiotherapy within the past 36 months", " Must have at least one undissected axillary and/or inguinal lymph node basin", " No history of brain metastases", " Hormone receptor status", " Estrogen receptor-positive or -negative tumor", " PATIENT CHARACTERISTICS:", " ECOG performance status of 0 or 1", " Body weight > 110 lbs (without clothes)", " Male or female", " Menopausal status not specified", " Absolute neutrophil count > 1000/mm^3", " Platelet count > 100,000/mm^3", " Hemoglobin > 9 g/dL", " Hemoglobin A1c < 7%", " AST and ALT 2.5 x upper limit of normal (ULN)", " Bilirubin 2.5 x ULN", " Alkaline phosphatase 2.5 x ULN", " Creatinine 1.5 x ULN", " HIV negative", " Hepatitis C negative", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No known or suspected allergies to any component of the vaccine", " No active infection requiring antibiotics", " No New York Heart Association class III or IV heart disease", " No autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement, except the following:", " Laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms", " Clinical evidence of vitiligo", " Other forms of depigmenting illness", " Mild arthritis requiring nonsteroidal antiinflammatory drugs", " No medical contraindication or potential problem that would preclude study participation", " PRIOR CONCURRENT THERAPY:", " More than 4 weeks since prior surgery", " More than 4 weeks since prior and no concurrent chemotherapy and radiotherapy", " More than 4 weeks since prior and no concurrent allergy desensitization injections", " More than 4 weeks since prior parenteral, oral, or inhaled corticosteroids", " No concurrent inhaled steroids (e.g., Advair® or triamcinolone acetonide)", " Prior or concurrent topical corticosteroids allowed", " More than 4 weeks since prior and no concurrent growth factors (e.g., epoetin alfa, darbepoetin alfa, or pegfilgrastim)", " More than 4 weeks since prior and no concurrent other investigational medication", " More than 4 weeks since prior and no concurrent other agents with putative immunomodulating activity except for non-steroidal anti-inflammatory agents", " Prior and concurrent hormonal therapy (e.g., tamoxifen, raloxifene, toremifene, fulvestrant, letrozole, anastrozole, or exemestane) allowed", " No prior vaccination with any synthetic peptides in this protocol", " Vaccines for infectious disease (e.g., influenza) allowed, provided they are administered 2 weeks prior to or 2 weeks after study vaccine", " Short term therapy for acute conditions not related to breast cancer allowed", " No concurrent illegal drugs" ]

[ "INTERVENTION 1: ", " Physician's Choice", " Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.", "INTERVENTION 2: ", " Niraparib", " Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops" ]

[ "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" ]

[ "Outcome Measurement: ", " Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period", " Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.", " Time frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)", "Results 1: ", " Arm/Group Title: Cohort A: SC Herceptin by Needle/Syringe", " Arm/Group Description: Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.", " Overall Number of Participants Analyzed: 1864", " Measure Type: Number", " Unit of Measure: percentage of participants 88.6", "Results 2: ", " Arm/Group Title: Cohort B: SC Herceptin by SID", " Arm/Group Description: Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.", " Overall Number of Participants Analyzed: 709", " Measure Type: Number", " Unit of Measure: percentage of participants 89.0" ]

[ "Adverse Events 1:", " Total: 3/9 (33.33%)", " Fatigue * 1/9 (11.11%)", " Non-cardiac chest pain * 1/9 (11.11%)", " Sepsis * 1/9 (11.11%)", " Urinary tract infection * 1/9 (11.11%)", " Syncope * 1/9 (11.11%)", " Anxiety * 1/9 (11.11%)", " Thromboembolic event * 1/9 (11.11%)" ]

[ "Outcome Measurement: ", " Percentage of Participants by Preferred Method of Drug Administration", " The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, \"All things considered, which method of administration did you prefer?\" at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported.", " Time frame: Week 24", "Results 1: ", " Arm/Group Title: Cohort 1: SC (SID) Then IV Herceptin", " Arm/Group Description: Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.", " Overall Number of Participants Analyzed: 117", " Measure Type: Number", " Unit of Measure: percentage of participants SC Herceptin: 95.7", " IV Herceptin: 4.3", " No Preference: 0.0", "Results 2: ", " Arm/Group Title: Cohort 1: IV Then SC (SID) Herceptin", " Arm/Group Description: Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.", " Overall Number of Participants Analyzed: 119", " Measure Type: Number", " Unit of Measure: percentage of participants SC Herceptin: 87.4", " IV Herceptin: 9.2", " No Preference: 3.4" ]

[ "INTERVENTION 1: ", " Triptorelin Plus Tamoxifen", " Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.", "INTERVENTION 2: ", " Triptorelin Plus Exemestane", " Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years." ]

[ "INTERVENTION 1: ", " LBH589 With Capecitabine", " MTD, LBH589 with Capecitabine", " LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.", " Capecitabine: Capecitabine will be administered orally twice daily for 14 days out of every 21 days.", "INTERVENTION 2: ", " LBH589 and Lapatinib", " LBH589 and Lapatinib", " LBH589: LBH589 will be evaluated when administered twice weekly at the following possible dose levels: 20 mg, 30 mg, 45 mg, and 60 mg. Capecitabine will be paired with LBH589 and will range in dose from 825 mg/m2 to 1250 mg/m2 orally BID 14 of every 21 days. Treatment cycles will be 21 days in length. Once determined safe, 10 additional patients will be treated at the determined MTD to further assess safety.", " Lapatinib: Lapatinib, 1000 mg PO daily will be added to this combination." ]

[ "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%)" ]

[ "Adverse Events 1:", " Total: 146/573 (25.48%)", " Anaemia 4/573 (0.70%)", " Disseminated intravascular coagulation 0/573 (0.00%)", " Neutropenia 1/573 (0.17%)", " Thrombocytopenia 0/573 (0.00%)", " Acute coronary syndrome 1/573 (0.17%)", " Angina pectoris 1/573 (0.17%)", " Atrial fibrillation 2/573 (0.35%)", " Atrial flutter 0/573 (0.00%)", " Cardiac arrest 1/573 (0.17%)", " Cardiac failure 0/573 (0.00%)", "Adverse Events 2:", " Total: 101/570 (17.72%)", " Anaemia 3/570 (0.53%)", " Disseminated intravascular coagulation 1/570 (0.18%)", " Neutropenia 1/570 (0.18%)", " Thrombocytopenia 1/570 (0.18%)", " Acute coronary syndrome 0/570 (0.00%)", " Angina pectoris 1/570 (0.18%)", " Atrial fibrillation 0/570 (0.00%)", " Atrial flutter 1/570 (0.18%)", " Cardiac arrest 0/570 (0.00%)", " Cardiac failure 1/570 (0.18%)" ]

[ "Adverse Events 1:", " Total: 15/52 (28.85%)", " Anaemia * 1/52 (1.92%)", " Febrile neutropenia 24/52 (7.69%)", " Neutropenia 28/52 (15.38%)", " Cardiac failure chronic 21/52 (1.92%)", " Vomiting 23/52 (5.77%)", " Diarrhoea 21/52 (1.92%)", " Gastric ulcer 21/52 (1.92%)", " Gastritis 21/52 (1.92%)", " Nausea 21/52 (1.92%)", " Fatigue 21/52 (1.92%)", " Pyrexia 21/52 (1.92%)", " Gastroenteritis 21/52 (1.92%)" ]

[ "Adverse Events 1:", " Total: 2/7 (28.57%)", " Anaemia * 0/7 (0.00%)", " Iron Deficiency Anaemia * 0/7 (0.00%)", " Pericardial Effusion * 0/7 (0.00%)", " Adrenal Insufficiency * 1/7 (14.29%)", " Abdominal Pain * 0/7 (0.00%)", " Gastritis Erosive * 0/7 (0.00%)", " Urosepsis * 0/7 (0.00%)", " Pneumonia * 0/7 (0.00%)", " Urinary Tract Infection * 0/7 (0.00%)", " Enterocolitis infectious * 0/7 (0.00%)", "Adverse Events 2:", " Total: 1/8 (12.50%)", " Anaemia * 1/8 (12.50%)", " Iron Deficiency Anaemia * 0/8 (0.00%)", " Pericardial Effusion * 0/8 (0.00%)", " Adrenal Insufficiency * 0/8 (0.00%)", " Abdominal Pain * 0/8 (0.00%)", " Gastritis Erosive * 0/8 (0.00%)", " Urosepsis * 0/8 (0.00%)", " Pneumonia * 0/8 (0.00%)", " Urinary Tract Infection * 0/8 (0.00%)", " Enterocolitis infectious * 0/8 (0.00%)" ]

[ "Adverse Events 1:", " Total: 3/8 (37.50%)", " Anaemia 0/8 (0.00%)", " Febrile neutropenia 0/8 (0.00%)", " Polycythaemia 0/8 (0.00%)", " Acute coronary syndrome 0/8 (0.00%)", " Vertigo 0/8 (0.00%)", " Eyelid oedema 1/8 (12.50%)", " Constipation 0/8 (0.00%)", " Diarrhoea 0/8 (0.00%)", " Nausea 0/8 (0.00%)", " Stomatitis 0/8 (0.00%)", " Upper gastrointestinal haemorrhage 0/8 (0.00%)", " Vomiting 0/8 (0.00%)", " Chest pain 0/8 (0.00%)", "Adverse Events 2:", " Total: 2/6 (33.33%)", " Anaemia 0/6 (0.00%)", " Febrile neutropenia 0/6 (0.00%)", " Polycythaemia 0/6 (0.00%)", " Acute coronary syndrome 0/6 (0.00%)", " Vertigo 0/6 (0.00%)", " Eyelid oedema 0/6 (0.00%)", " Constipation 0/6 (0.00%)", " Diarrhoea 0/6 (0.00%)", " Nausea 0/6 (0.00%)", " Stomatitis 0/6 (0.00%)", " Upper gastrointestinal haemorrhage 0/6 (0.00%)", " Vomiting 0/6 (0.00%)", " Chest pain 1/6 (16.67%)" ]

[ "INTERVENTION 1: ", " Treatment (Neoadjuvant Chemotherapy Before Surgery)", " Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.", " sunitinib malate: Given PO", " paclitaxel: Given IV", " doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given PO", " filgrastim: Given SC", " therapeutic conventional surgery: Undergo surgery", " laboratory biomarker analysis: Correlative studies", " flow cytometry: Correlative studies" ]

[ "INTERVENTION 1: ", " Manual Lymph Drainage", " Manual lymph drainage (MLD) treatment 3 times a week for 4 weeks to the lymphedematous upper limb", " Manual Lymph Drainage (MLD): MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.", "INTERVENTION 2: ", " Negative Pressure", " PhysioTouch (negative pressure massage) treatment 3 times a week for 4 weeks to the lymphedematous upper limb", " PhysioTouch: The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia." ]

[ "INTERVENTION 1: ", " No Exercise", " Multivitamin Arm + Calcitriol Arm:Calcitriol pill taken once per week", "INTERVENTION 2: ", " Exercise", " Exercise Arm: Exercise consisting of progressive walking and resistance band training", " Calcitriol+ Exercise Arm: Calcitriol pill taken once per week + Exercise" ]

[ "Outcome Measurement: ", " Objective Response Rate", " Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.", " Time frame: Baseline to 6 months", "Results 1: ", " Arm/Group Title: Abraxane + Tigatuzumab", " Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.", " Overall Number of Participants Analyzed: 39", " Measure Type: Number", " Unit of Measure: percentage of patients 28 (14.9 to 45.0)", "Results 2: ", " Arm/Group Title: Abraxane Alone", " Arm/Group Description: Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).", " Overall Number of Participants Analyzed: 21", " Measure Type: Number", " Unit of Measure: percentage of patients 38 (18 to 61.1)" ]

[ "Adverse Events 1:", " Total: 78/284 (27.46%)", " Febrile neutropenia * 28/284 (9.86%)", " Neutropenia * 217/284 (5.99%)", " Leukopenia * 23/284 (1.06%)", " Anaemia * 22/284 (0.70%)", " Thrombocytopenia * 20/284 (0.00%)", " Myocardial infarction * 20/284 (0.00%)", " Arrhythmia * 21/284 (0.35%)", " Atrial fibrillation * 1/284 (0.35%)", " Coronary artery disease * 20/284 (0.00%)", " Left ventricular dysfunction * 21/284 (0.35%)", "Adverse Events 2:", " Total: 7/92 (7.61%)", " Febrile neutropenia * 0/92 (0.00%)", " Neutropenia * 20/92 (0.00%)", " Leukopenia * 20/92 (0.00%)", " Anaemia * 20/92 (0.00%)", " Thrombocytopenia * 20/92 (0.00%)", " Myocardial infarction * 20/92 (0.00%)", " Arrhythmia * 20/92 (0.00%)", " Atrial fibrillation * 0/92 (0.00%)", " Coronary artery disease * 20/92 (0.00%)", " Left ventricular dysfunction * 20/92 (0.00%)" ]

[ "INTERVENTION 1: ", " Lapatinib Monotherapy", " Lapatinib: 1500 mg (six 250 mg tablets) orally once daily" ]

[ "Adverse Events 1:", " Total: 52/133 (39.10%)", " Thrombocytopenia 2/133 (1.50%)", " Anaemia 1/133 (0.75%)", " Disseminated intravascular coagulation 0/133 (0.00%)", " Atrial thrombosis 1/133 (0.75%)", " Cardiac failure 0/133 (0.00%)", " Vertigo 0/133 (0.00%)", " Vomiting 3/133 (2.26%)", " Nausea 1/133 (0.75%)", " Colitis 1/133 (0.75%)", " Constipation 1/133 (0.75%)", " Enteritis 0/133 (0.00%)", " Abdominal pain 0/133 (0.00%)", "Adverse Events 2:", " Total: 16/67 (23.88%)", " Thrombocytopenia 0/67 (0.00%)", " Anaemia 0/67 (0.00%)", " Disseminated intravascular coagulation 1/67 (1.49%)", " Atrial thrombosis 0/67 (0.00%)", " Cardiac failure 1/67 (1.49%)", " Vertigo 1/67 (1.49%)", " Vomiting 0/67 (0.00%)", " Nausea 1/67 (1.49%)", " Colitis 0/67 (0.00%)", " Constipation 0/67 (0.00%)", " Enteritis 1/67 (1.49%)", " Abdominal pain 2/67 (2.99%)" ]

[ "Inclusion Criteria:", " Signed and dated PICF obtained prior to initiation of any study-specific procedure and treatment.", " Female 18 years old.", " Histologically proven invasive breast carcinoma (through either a core needle biopsy or an incisional biopsy) for which surgery is indicated as the primary treatment modality. Patients for which Neoadjuvant Systemic Therapy (NAST) is indicated are also eligible provided they are willing to undergo a biopsy after completing treatment with darolutamide and prior to NAST start.", " Known ER, PgR and HER2 statuses.", " Tumor must be confined to either the breast or to the breast and ipsilateral axilla (Note: patinets with multifocal/multicentric tumors are eligible). Patient must have (according to TNM 7th edition rules):", " T1 with T 1.0cm, T2 or T3 by at least one radiographic or clinical measurement", " Either clinically positive (N1 only) or clinically negative axillary nodes (N0)", " M0", " Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.", " Adequate organ function within 28 days prior to enrollment, as defined by the following criteria:", " Hematology: Hemoglobin 9.0 g/dl; ANC 1.5 × 109/L; Platelet count 100 × 109/L", " Liver function: ALT and AST 2.5 × ULN; Total bilirubin 1.5 × ULN (or 3 times ULN for patients with documented Gilbert's syndrome or for whom indirect bilirubin concentrations suggest an extra-hepatic source of elevation)", " Renal function: Creatinine 2.0 × ULN", " No more than 42 days should elapse from the day study-specific tumor sample is taken at initial diagnosis (or subsequent procedure) to the day of the first intake of darolutamide.", " Women of childbearing potential (WoCBP)* must agree to use acceptable non-hormonal contraceptive methods of birth control from the day of the screening pregnancy test and up to 3 months after the last intake of darolutamide.", " For WoCBP* negative serum pregnancy test within 7 days of enrollment.", " Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and biopsies as detailed in the protocol.", " Note: WoCBP are any women between menarche and menopause who have not been permanently sterilized, capable of procreation. Permanent sterilization includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal ligation/occlusion. Postmenopause is defined as: Bilateral oophorectomy; Age 60; Age < 60 and amenorrheic for 12 months in the absence of an alternative medical cause and FSH and estradiol in postmenopausal ranges.", "Exclusion Criteria:", " Any T0, Tis, T1 < 1.0 cm, T4; or N2-3; or M1 BC.", " Bilateral invasive BC.", " Patient that underwent excisional biopsy of the primary tumor.", " Medical indication or patient desire to undergo BC surgery or start NAST prior to completing at least 14 days of treatment with darolutamide, and or refusal of patient to undergo corresponding biopsy in case NAST is planned.", " Prior or concurrent systemic anticancer therapy for BC treatment(immunotherapy, hormonotherapy, biologic/targeted therapy, chemotherapy, investigational agents).", " Prior or concurrent ipsilateral radiation therapy for invasive or noninvasive BC.", " Prior or concurrent treatment or preventative use of any hormonal agent such as aromatase inhibitors (AI), fulvestrant, raloxifene, tamoxifen or other SERM, or with any other hormonal agent used for the treatment or prevention of BC or for any other indication (e.g. osteoporosis).", " Concurrent use of ovarian hormone replacement therapy. Prior treatment should be stopped at least 28 days prior to registration.", " Prior or concurrent treatment with AR antagonists or CYP17 enzyme inhibitor.", " Use of other investigational drug within 28 days of enrollment.", " Major surgery* within 28 days before enrollment.", " Any concurrent or previous malignancy within 5 years prior to enrollment except for basal or squamous skin cancer, or carcinoma in situ of the cervix, or other non-invasive/in-situ neoplasm, all of which must have been adequately and radically treated. A patient with previous history of invasive malignancy (other than adequately and radically treated basal or squamous skin cancer) is eligible provided that she has been disease free for more than 5 years.", " Severe or uncontrolled concurrent disease, infection or comorbidity.", " Known active viral hepatitis, HIV or chronic liver disease.", " Other serious illness or medical condition within 6 months before enrollment, including any of the following: Concurrent congestive heart failure NYHA Class III or IV, severe/unstable angina pectoris, myocardial infarction, uncontrolled hypertension, coronary/peripheral artery bypass graft, high-risk uncontrolled arrhythmias, stroke.", " Any contraindication to oral agents or gastrointestinal disorder or procedure which expects to interfere significantly with absorption of protocol treatment.", " History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.", " Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.", " Known allergy to darolutamide or any of the excipients.", " Pregnant or lactating darolutamide. * Note: Major surgery defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability." ]

[ "Outcome Measurement: ", " Progression Free Survival", " [Not Specified]", " Time frame: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.", "Results 1: ", " Arm/Group Title: A (Sorafenib + Gemcitabine or Capecitabine)", " Arm/Group Description: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)", " Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle", " Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)", " Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).", " Overall Number of Participants Analyzed: 81", " Median (95% Confidence Interval)", " Unit of Measure: Days 103 (83 to 128)", "Results 2: ", " Arm/Group Title: B (Placebo + Gemcitabine or Capecitabine)", " Arm/Group Description: Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)", " Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle", " Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)", " Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).", " Overall Number of Participants Analyzed: 79", " Median (95% Confidence Interval)", " Unit of Measure: Days 81 (48 to 95)" ]

[ "Outcome Measurement: ", " Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)", " Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.", " Time frame: Baseline, 12 months", "Results 1: ", " Arm/Group Title: Zoledronic Acid Upfront", " Arm/Group Description: Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.", " Letrozole : Participants received 2.5 mg daily.", " Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.", " Overall Number of Participants Analyzed: 253", " Mean (Standard Deviation)", " Unit of Measure: Percentage of BMD 1.955 (3.3658)", "Results 2: ", " Arm/Group Title: Zoledronic Acid Delayed-start", " Arm/Group Description: In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.", " Letrozole : Participants received 2.5 mg daily.", " Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months.", " Overall Number of Participants Analyzed: 256", " Mean (Standard Deviation)", " Unit of Measure: Percentage of BMD -2.325 (3.9542)" ]

[ "Outcome Measurement: ", " Phase 1: Number of Subjects Reporting Dose-Limiting Toxicities (DLTs)", " DLTs are defined as: Any treatment-related Grade 3 non-hematologic clinical (non-laboratory) AE Any treatment-related Grade 3 or Grade 4 non-hematologic lab abnormality if: - Medical intervention is required to treat the patient, or - The abnormality leads to hospitalization, or - The abnormality persists for 7 days. Any treatment-related hematologic toxicity specifically defined as: - Thrombocytopenia Grade 4 for 7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion; - Neutropenia Grade 4 for 7 days, or Grade 3 or 4 associated with infection or febrile neutropenia; - Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion. Any treatment-related AE leading to niraparib dose interruption per the following criteria: - A dose interruption for a non-DLT lab abnormality lasting 14 days. - A dose in interruption per dose modification rules for nonhematologic AE leading to < 80% of an intended dose being administered.", " Time frame: During Cycle 1, ie, during the first 21 days of treatment", "Results 1: ", " Arm/Group Title: Phase 1: Niraparib 200mg + Pembrolizumab", " Arm/Group Description: Niraparib 200 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%", "Results 2: ", " Arm/Group Title: Phase 1: Niraparib 300mg + Pembrolizumab", " Arm/Group Description: Niraparib 300 mg/day orally (PO). Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%" ]

[ "Outcome Measurement: ", " Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy", " A pCR in the breast was defined as no pathologic evidence of invasive disease (residual ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS] was allowed). A pCR in the axillary lymph node(s) was defined as no evidence of breast cancer cells in the lymph node (including subcapsular sinus). Overall pCR was defined as the sum of pCR in the breast and pCR in the lymph nodes. 26 weeks of therapy comprised the 2-week run-in phase, 12 weeks of treatment with FEC, and 12 weeks of treatment with Paclitaxel.", " Time frame: Week 26", "Results 1: ", " Arm/Group Title: Trastuzumab", " Arm/Group Description: Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.", " Overall Number of Participants Analyzed: 26", " Measure Type: Number", " Unit of Measure: percentage of participants 54.0", "Results 2: ", " Arm/Group Title: Lapatinib", " Arm/Group Description: Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.", " Overall Number of Participants Analyzed: 29", " Measure Type: Number", " Unit of Measure: percentage of participants 45.0" ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed invasive adenocarcinoma of the breast, meeting 1 of the following high-risk criteria:", " T3 or T4 primary tumor", " 4 or more involved axillary lymph nodes (N2 nodal stage)", " Completed surgical excision", " No immediate reconstruction with autologous flap reconstruction", " Patients having tissue expanders or implants placed prior to radiation may be enrolled at the physician's discretion", " No residual breast cancer", " Microscopically positive margins are allowed if a re-excision is not felt to be clinically justified", " Candidate for radiotherapy", " Must not require bilateral radiotherapy", " No metastatic (stage IV) breast cancer by AJCC staging criteria", " Hormone receptor status not specified", " No CNS disorders", " PATIENT CHARACTERISTICS:", " Life expectancy 6 months", " Karnofsky performance status 70-100%", " Menopausal status not specified", " Ambulatory", " Hemoglobin > 9 g/dL", " Platelet count > 100,000/mm³", " ANC > 1,500/mm³", " Serum AST, ALT, and alkaline phosphatase 2 times upper limit of normal (ULN)", " Total bilirubin normal", " Creatinine clearance > 50 mL/min", " Negative pregnancy test", " Not pregnant or nursing", " Fertile patients must use effective contraception during study and for 30 days after the last study drug administration", " No serious, uncontrolled, concurrent infection(s)", " No diabetes with current or history of delayed wound healing or skin ulcers", " No autoimmune connective tissue disorder", " No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency", " No other carcinomas within the last five years except cured non-melanoma skin cancer and in-situ cervical cancer", " No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months", " No other serious uncontrolled medical conditions that the investigator feels might compromise study participation, including any of the following:", " Uncontrolled seizures", " Psychiatric disability judged by the investigator to be clinically significant", " Physically intact upper gastrointestinal tract", " No malabsorption syndrome", " No uncompensated coagulopathy", " No patients whose breast size or body contour puts them at increased risk for skin desquamation from standard radiotherapy", " Able to read and speak English", " PRIOR CONCURRENT THERAPY:", " Fully recovered from surgery and chemotherapy with completely healed surgical wounds", " At least 4 weeks since completion of prior chemotherapy regimen, excluding trastuzumab (Herceptin®)", " Concurrent trastuzumab allowed at the physician's discretion", " More than 4 weeks since prior participation in any investigational drug study", " At least 4 weeks since prior and no concurrent sorivudine or brivudine", " More than 2 weeks since prior major surgery", " No prior capecitabine", " No prior radiotherapy to the chest or ipsilateral lymphatics", " No concurrent hormonal therapy during course of chemotherapy or radiation therapy", " No concurrent allopurinol or cimetidine", " Concurrent coumadin is allowed" ]

[ "Adverse Events 1:", " Total: 31/185 (16.76%)", " Anemic Shock [1]1/185 (0.54%)", " Febrile Neutropenia [2]13/185 (7.03%)", " Febrile Neutropenia 2/185 (1.08%)", " Febrile neutropenia [3]3/185 (1.62%)", " Neutrophil Count Decreased [2]2/185 (1.08%)", " Neutrophil Count Decreased [3]2/185 (1.08%)", " Neutrophil Count Decreased [4]2/185 (1.08%)", " Colon Diverticulitis 1/185 (0.54%)", " Vomiting [2]1/185 (0.54%)" ]

[ "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)" ]

[ "Inclusion Criteria:", " At least 18 years of age", " Willing and able to provide informed consent", " Reporting daily hot flashes", " Able to read, write, and speak English", " Postmenopausal to limit sample variability (> 12 months amenorrhea)", " Greater then 1 month but < 5 years post-treatment (surgery, radiation, chemotherapy) for non-metastatic breast cancer.", " These criteria allow inclusion of women successfully treated for recurrent breast cancer since there is no known reason to exclude them. Menopausal status is assessed using self-reports due to problems in reliably measuring follicle-stimulating hormone levels and estradiol in tamoxifen users.", "Exclusion Criteria:", " Exclusion criteria are current depression, history of migraines or hepatitis, abnormal chemistry profile (e.g., sodium, potassium, glucose), or a positive urine drug screen for illegal substances." ]

[ "Outcome Measurement: ", " Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples", " tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is [i.e.], ypT0/is, ypN0 in the American Joint Committee on Cancer [AJCC] staging system, 7th edition). Percentage of participants with tpCR was reported.", " Time frame: Pre-surgery (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)", "Results 1: ", " Arm/Group Title: TCH + P", " Arm/Group Description: Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).", " Overall Number of Participants Analyzed: 221", " Measure Type: Number", " Unit of Measure: Percentage of Participants 56.1 (49.29 to 62.76)", "Results 2: ", " Arm/Group Title: T-DM1 + P", " Arm/Group Description: Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).", " Overall Number of Participants Analyzed: 223", " Measure Type: Number", " Unit of Measure: Percentage of Participants 44.4 (37.76 to 51.18)" ]

[ "Adverse Events 1:", " Total: 10/30 (33.33%)", " Hemoglobin decreased 2/30 (6.67%)", " Abdominal pain 1/30 (3.33%)", " Colitis 1/30 (3.33%)", " Diarrhea 7/30 (23.33%)", " Nausea 2/30 (6.67%)", " Rectal hemorrhage 1/30 (3.33%)", " Fatigue 1/30 (3.33%)", " Skin infection 1/30 (3.33%)", " Neutrophil count decreased 1/30 (3.33%)", " Platelet count decreased 3/30 (10.00%)", " Dehydration 1/30 (3.33%)" ]

[ "Adverse Events 1:", " Total: 78/284 (27.46%)", " Febrile neutropenia * 28/284 (9.86%)", " Neutropenia * 217/284 (5.99%)", " Leukopenia * 23/284 (1.06%)", " Anaemia * 22/284 (0.70%)", " Thrombocytopenia * 20/284 (0.00%)", " Myocardial infarction * 20/284 (0.00%)", " Arrhythmia * 21/284 (0.35%)", " Atrial fibrillation * 1/284 (0.35%)", " Coronary artery disease * 20/284 (0.00%)", " Left ventricular dysfunction * 21/284 (0.35%)", "Adverse Events 2:", " Total: 7/92 (7.61%)", " Febrile neutropenia * 0/92 (0.00%)", " Neutropenia * 20/92 (0.00%)", " Leukopenia * 20/92 (0.00%)", " Anaemia * 20/92 (0.00%)", " Thrombocytopenia * 20/92 (0.00%)", " Myocardial infarction * 20/92 (0.00%)", " Arrhythmia * 20/92 (0.00%)", " Atrial fibrillation * 0/92 (0.00%)", " Coronary artery disease * 20/92 (0.00%)", " Left ventricular dysfunction * 20/92 (0.00%)" ]

[ "Outcome Measurement: ", " Progression-free Survival (PFS)", " PFS is defined as the number of months from the date of randomization to the earlier of progressive disease (PD) or death due to any cause.", " Time frame: From date of randomization to discontinuation due to disease progression or death up to primary completion date (Median follow-up 6 months)", "Results 1: ", " Arm/Group Title: Exemestane 25 mg + Placebo", " Arm/Group Description: Exemestane (Aromasin ) 25 mg tablets orally once daily plus a placebo-matching entinostat tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.", " Overall Number of Participants Analyzed: 66", " Median (95% Confidence Interval)", " Unit of Measure: months 2.27 (1.81 to 3.68)", "Results 2: ", " Arm/Group Title: Exemestane 25 mg + Entinostat 5 mg", " Arm/Group Description: Exemestane (Aromasin ) 25 mg tablets orally once daily plus an entinostat 5 mg tablet orally once per week on Days 1, 8, 15 and 22 of each 28-day treatment cycle until development of progressive disease (PD) or unacceptable toxicity or closure of the study by the Sponsor, whichever occurred first.", " Overall Number of Participants Analyzed: 64", " Median (95% Confidence Interval)", " Unit of Measure: months 4.28 (3.26 to 5.36)" ]

[ "Outcome Measurement: ", " Congestive Heart Failure Rate", " Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.", " Time frame: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry", "Results 1: ", " Arm/Group Title: Arm A (ddBAC > BT > B)", " Arm/Group Description: Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab", " Overall Number of Participants Analyzed: 103", " Measure Type: Number", " Unit of Measure: percentage of participants 2.9 (0.6 to 8.3)", "Results 2: ", " Arm/Group Title: Arm B (ddAC > BT > B)", " Arm/Group Description: Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab", " Overall Number of Participants Analyzed: 120", " Measure Type: Number", " Unit of Measure: percentage of participants 2.5 (0.5 to 7.1)" ]

[ "Adverse Events 1:", " Total: 15/48 (31.25%)", " Anemia * 1/48 (2.08%)", " Cardiac failure congestive * 1/48 (2.08%)", " Constipation * 2/48 (4.17%)", " Esophagitis * 1/48 (2.08%)", " Gastrointestinal hemorrhage * 1/48 (2.08%)", " Non-Cardiac chest pain * 1/48 (2.08%)", " Pain * 1/48 (2.08%)", " Cholecystitis * 1/48 (2.08%)", " Diverticulitis * 1/48 (2.08%)", " Cellulitis * 1/48 (2.08%)", " Gastroenteritis * 1/48 (2.08%)" ]

[ "Inclusion Criteria:", " Operable breast cancer", "Exclusion Criteria:", " Inoperable breast cancer", " BMI > 25", " Neoadiuvant radioterapy", " Carcinomastitis", " Previous phlebitis of omolateral arm", "Collagen disease" ]

[ "Inclusion Criteria:", " Written informed consent of the patient signed by herself.", " Histologically confirmed metastatic or recurrent adenocarcinoma of the breast.", " Aged 20 to 74 at the time of informed consent.", "Exclusion Criteria:", " Prior systemic chemotherapy with taxane anticancer drugs for metastatic or recurrent breast cancer." ]

[ "Inclusion Criteria:", " Tissue block containing tumor to confirm metastatic breast cancer is required;", " Measurable disease according to RECIST criteria", " \"Triple negative\" disease defined as tumor demonstrating no expression for estrogen, progesterone or human epidermal growth factor receptor 2(HER2)receptors. \"No expression\" is categorized as 10% of cells staining or Allred 2;", " Aged 18 years or older;", " Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1; life expectancy 3 months;", " Patients may have received 0 - 1 prior therapies (except taxanes in the metastatic setting). An interval of at least 1 week must have elapsed since prior chemotherapy or hormonal therapy for metastatic disease; at least 6 months must have elapsed since prior adjuvant therapy;", " 2 weeks between surgery and study enrollment ( 4 weeks between major surgery (defined as open abdominal/thoracic/cardiac) and study enrollment;", " Laboratory tests performed within 14 days of study entry:", " Granulocytes 1,500/µL;", " Platelets 100,000/µL;", " Hemoglobin 9 gm/dL;", " Total bilirubin institutional upper limit of normal (ULN);", " Aspartate transaminase (AST) and alanine aminotransferase (ALT) 5 times ULN;", " Alkaline phosphatase 2.5 times ULN;", " Estimated creatinine clearance 60 mL/min.", " left ventricular ejection fraction (LVEF) 50% by multigated acquisition (MUGA)/Echocardiogram;", " Informed consent to receive protocol treatment, to provide biologic specimens, and to complete neurotoxicity questionnaires;", " Cognitive and communication skills to comply with study and/or follow-up procedures;", " No reproductive potential:", " If pre-menopausal: Negative serum pregnancy test and patient agreement to use adequate contraceptive method (abstinence, intrauterine device, barrier device with spermicide or surgical sterilization) during and for 3 months after completion of treatment.", "If post-menopausal: Amenorrhea for 12 months.", "Exclusion Criteria:", " Pregnant or breast feeding;", " Prior treatment with Abraxane®, carboplatin or bevacizumab, or any taxane for metastatic breast cancer;", " Known hypersensitivity to any component of any study drug;", " Active infection;", " Current neuropathy grade 2;", " central nervous system (CNS) metastases as determined by head CT with contrast;", " History of bleeding within the past 6 months or active bleeding disorder;", " Serious non-healing wound, ulcer or bone fracture;", " Uncontrolled congestive heart failure (CHF), or history of myocardial infarction(MI), unstable angina, stroke, or transient ischemia within previous 6 months;", " Inadequately controlled hypertension (defined as systolic blood pressure < 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications; prior history of hypertensive crisis or hypertensive encephalopathy;", " Proteinuria (defined as urine protein: creatinine (UPC) ratio 1.0 or urine dipstick 2+.", " Significant vascular disease (aortic aneurysm, aortic dissection) or symptomatic peripheral vascular disease;", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within previous 6 months;", " Uncontrolled serious contraindicated medical condition or psychiatric illness." ]

[ "INCLUSION CRITERIA:", " Undergoing core needle biopsy for a breast abnormality suspicious for breast cancer.", " Has undergone a core needle biopsy demonstrating breast cancer and has not yet had any further therapy, provided the core needle biopsy is available for analysis.", " No prior therapy for breast cancer within the past 5 years.", " 18 years of age or older.", " Ability to understand and the willingness to sign a written informed consent document.", "EXCLUSION CRITERIA:", " History of parathyroid disease, hypercalcemia, or kidney stones.", " Supplemental vitamin D other than from a standard multiple vitamin or from standard formulations of calcium and vitamin D (eg, calcium citrate with vitamin D) within the prior 6 months.", " History of renal failure requiring dialysis or kidney transplantation.", " Pregnant or nursing", " Receiving supplemental calcium > 1200 mg calcium per day during study.", " Initial treatment of breast cancer will not be with breast-conserving surgery or mastectomy.", " Locally-advanced breast cancer", " Plans for neoadjuvant chemotherapy, hormonal therapy, or other systemic therapy", " Plans for preoperative radiation therapy", " Plans for breast cancer surgery, and does not allow for at least 10 days of vitamin D intervention.", " Any condition potentially interfering with subjects ability to comply with taking study medication.", " Any medical condition that would potentially interfere with vitamin D absorption, such as celiac sprue, ulcerative colitis.", " Current participation in another research study that would increase risk to subject, in the opinion of the investigators" ]

[ "Outcome Measurement: ", " Percentage Change in Bone Mineral Density (BMD) of the Lumbar Spine (L2-L4) at 12 Months of Therapy.", " Bone Mineral Density (g/cm^2) of the Lumbar Spine (L2-L4) as measured by energy x-ray absorptiometry (DXA).", " Time frame: Baseline, 12 months", "Results 1: ", " Arm/Group Title: Zoledronic Acid 4 mg Upfront", " Arm/Group Description: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.", " Overall Number of Participants Analyzed: 423", " Mean (Standard Deviation)", " Unit of Measure: Percentage change in BMD 2.208 (3.4194)", "Results 2: ", " Arm/Group Title: Zoledronic Acid 4 mg Delayed", " Arm/Group Description: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.", " Overall Number of Participants Analyzed: 418", " Mean (Standard Deviation)", " Unit of Measure: Percentage change in BMD -3.617 (4.2151)" ]

[ "Outcome Measurement: ", " Clinical Benefit Rate (Complete Response, Partial Response, or Stable Disease)", " Response evaluation criteria in solid tumors (RECIST) criteria version 1.0 was used for response evaluation. Clinical benefit rate is defined as the proportion of subjects experiencing a complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks.", " Evaluation of target lesions: Complete Response (CR)-- Disappearance of all target lesions; Partial Response (PR)-- At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Stable Disease (SD)-- Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;", " Evaluation of non-target lesions: Complete Response (CR)-- Disappearance of all non-target lesions and normalization of tumor marker level; Incomplete Response/ Stable Disease (SD)-- Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits", " Time frame: Up to 24 months", "Results 1: ", " Arm/Group Title: Treatment (Temsirolimus)", " Arm/Group Description: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " Temsirolimus: Given IV", " Overall Number of Participants Analyzed: 31", " Measure Type: Number", " Unit of Measure: percentage of participants 9.7" ]

[ "Adverse Events 1:", " Total: 10/76 (13.16%)", " Sickle cell anaemia with crisis 1/76 (1.32%)", " Diarrhoea 1/76 (1.32%)", " Pyrexia 1/76 (1.32%)", " Chest pain 1/76 (1.32%)", " Complication associated with device 1/76 (1.32%)", " General physical health deterioration 0/76 (0.00%)", " Device related infection 2/76 (2.63%)", " Pneumonia 1/76 (1.32%)", " Atypical pneumonia 1/76 (1.32%)", " Dehydration 1/76 (1.32%)", "Adverse Events 2:", " Total: 3/75 (4.00%)", " Sickle cell anaemia with crisis 0/75 (0.00%)", " Diarrhoea 0/75 (0.00%)", " Pyrexia 1/75 (1.33%)", " Chest pain 0/75 (0.00%)", " Complication associated with device 0/75 (0.00%)", " General physical health deterioration 1/75 (1.33%)", " Device related infection 0/75 (0.00%)", " Pneumonia 1/75 (1.33%)", " Atypical pneumonia 0/75 (0.00%)", " Dehydration 0/75 (0.00%)" ]

[ "Adverse Events 1:", " Total: 16/56 (28.57%)", " Pancytopenia 0/56 (0.00%)", " Pericarditis 0/56 (0.00%)", " Abdominal pain 1/56 (1.79%)", " Anal fissure 1/56 (1.79%)", " Ascites 1/56 (1.79%)", " Constipation 0/56 (0.00%)", " Diarrhoea 1/56 (1.79%)", " Nausea 0/56 (0.00%)", " Oesophageal pain 0/56 (0.00%)", " Vomiting 0/56 (0.00%)", " Disease progression 2/56 (3.57%)", " Infusion related reaction 1/56 (1.79%)", " Pain 0/56 (0.00%)", "Adverse Events 2:", " Total: 11/37 (29.73%)", " Pancytopenia 1/37 (2.70%)", " Pericarditis 1/37 (2.70%)", " Abdominal pain 2/37 (5.41%)", " Anal fissure 0/37 (0.00%)", " Ascites 0/37 (0.00%)", " Constipation 1/37 (2.70%)", " Diarrhoea 1/37 (2.70%)", " Nausea 2/37 (5.41%)", " Oesophageal pain 1/37 (2.70%)", " Vomiting 2/37 (5.41%)", " Disease progression 2/37 (5.41%)", " Infusion related reaction 0/37 (0.00%)", " Pain 1/37 (2.70%)" ]

[ "Inclusion Criteria:", " Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.", "Exclusion Criteria:", " Ductal carcinoma in situ (DCIS; stage 0 cancer),", " Advanced or distant metastatic stage,", " Receiving any neoadjuvant therapy,", " History of receiving any antibiotics within prior 3 months,", " History of immunodeficiency,", " Having a remote infection,", " History of reaction to study antibiotics,", " Denial of signing the consent form." ]

[ "Inclusion Criteria:", " Age 18 years", " Stage 1-4 invasive breast cancer that is histologically confirmed at MSKCC", " Status post mastectomy with axillary exploration (sentinel node biopsy and/or axillary lymph node dissection) to receive PMRT", " ECOG Performance Status of 0 or 1", "Exclusion Criteria:", " Male", " Patients with clinical evidence of gross disease", " Patients who are pregnant or breastfeeding", " Prior radiation therapy to the ipsilateral chest wall or thorax", " Patients requiring a chest wall boost", " Concurrent chemotherapy (biologic agents are allowed)", " Psychiatric illness that would prevent the patient from giving informed consent", " Inability or unwillingness to comply with skin care instructions and follow-up", " Allergy to either Eucerin or MF", " Residual grade >1 skin toxicity, cellulitis, or incompletely healed wound(s) at intended site of study drug application at the time of the start of RT", " Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases)", " Treatment with palliative or pre-operative radiation" ]

[ "Eligibility Criteria:", " Must have invasive metastatic breast cancer", " Tumor must be Her 2/neu 3+ by IHC (must be confirmed by Ohio State University pathology)or positive FISH", " Histological confirmation of invasive breast cancer either from the original diagnosis and/or diagnosis of metastatic disease.", " Tumor must be detectable clinically or radiographically (a positive bone scan is allowed as the only site of disease). Unidimensional measurements must be obtained whenever possible). Bone marrow only disease is not eligible for enrollment on this study.", " No evidence of congestive heart failure, symptoms of coronary artery disease, serious cardiac arrhythmias, or evidence of prior myocardial infarction on EKG or ECHO. Patients must have normal LV function and LVEF(left ventricular ejection fraction)> 50% as demonstrated by either echo or muga within the proceeding 4 weeks.", " Must have adequate renal and hepatic function documented by a serum creatinine < 1.5 x the institutional upper limit of normal (ULN), serum bilirubin <1.5 x ULN and liver enzymes (AST, ALT, or alkaline phosphatase) < 2 x ULN (< 5 x ULN if hepatic metastasis) within 21 days prior to registration.", " Patients must have an ANC (absolute neutrophil count) > 1.5, platelets > 100,000, Hemoglobin >9.0 within 21 days of registration.", " If patients are on bisphosphonates at the time of registration, with a stable creatinine over the preceding 2 months, then they may continue bisphosphonates during the study.", " No more than one prior Trastuzumab/chemotherapy or Trastuzumab/biotherapy combination for metastatic disease. Additional Trastuzumab therapy may have been given in the adjuvant setting. Prior hormonal therapy is allowed for either adjuvant or metastatic disease.", " Must be >3 weeks since administration of last chemotherapy prior to initiation of treatment on this trial. Prior trastuzumab may have been administered within one week of initiation of treatment on this trial if the last dose was 2 mg/kg. Any prior trastuzumab dosing greater than 2 mg/kg requires a 3 week washout period.", " Patients may have received prior cisplatin or carboplatin for metastatic disease.", " No CNS(central nervous system)metastasis disease.", " No active infection at time of registration.", " Pregnant or nursing women may not participate in trial.", " Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.", " ECOG (Eastern Cooperative Oncology Group)performance status < 2 at the time of registration.", " Patients may participate in a non-treatment related protocol while participating in this study.", " No other active malignancy is allowed. Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years is allowed." ]

[ "Inclusion Criteria:", " women >=18 years of age;", " newly diagnosed;", " infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.", "Exclusion Criteria:", " evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;", " previous systemic or local primary treatment." ]

[ "Inclusion Criteria:", " Recent primary surgery for breast cancer", " Early stage breast cancer", " Postmenopausal", " Hormone receptor positive", " Positive lymph node involvement", "Exclusion Criteria:", " Metastatic disease", " Presence of contralateral breast cancer including DCIS", " Progression", " Other protocol-defined inclusion/exclusion criteria may apply." ]

[ "Inclusion Criteria:", " Metastatic adenocarcinoma of the breast (Stage IV)", " Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy)", " Minimum age 18 years", " ECOG Performance status of 0, 1 or 2", " Normal organ and marrow function as defined in the protocol", "Exclusion Criteria:", " Participants may not be receiving any other study agents", " Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks", " Any statin therapy within the last 3 weeks", " Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin)", " Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors", " Conditions predisposing to renal failure secondary to rhabdomyolysis", " Recent history of heavy alcohol use as judged by the treating physician", " Known to be pregnant (testing not required) or nursing", " History of rhabdomyolysis on statin therapy", " Known history of Hepatitis C or active hepatitis B infection (baseline testing not required)", " Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements" ]

[ "Adverse Events 1:", " Total: 1/22 (4.55%)", " Blood bilirubin increased 1/22 (4.55%)", " Alkaline phosphatase increased 1/22 (4.55%)" ]

[ "INTERVENTION 1: ", " Group 2 (RS 11-25)", " Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy." ]

[ "INTERVENTION 1: ", " AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib", " Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months." ]

[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicities (DLT)", " Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.", " Time frame: 28 days", "Results 1: ", " Arm/Group Title: Afatinib 20mg + Herceptin", " Arm/Group Description: Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.", " Overall Number of Participants Analyzed: 13", " Measure Type: Number", " Unit of Measure: Participants 4", "Results 2: ", " Arm/Group Title: Afatinib 30mg + Herceptin", " Arm/Group Description: Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.", " Overall Number of Participants Analyzed: 2", " Measure Type: Number", " Unit of Measure: Participants 2" ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease 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\". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).", " Time frame: Time from first dose to date of progression, the longest time frame of 79.1 weeks", "Results 1: ", " Arm/Group Title: MM-121 + Exemestane", " Arm/Group Description: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day", " Overall Number of Participants Analyzed: 56", " Median (95% Confidence Interval)", " Unit of Measure: weeks 15.9 (9.3 to 30.3)", "Results 2: ", " Arm/Group Title: Placebo + Exemestane", " Arm/Group Description: Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day", " Overall Number of Participants Analyzed: 59", " Median (95% Confidence Interval)", " Unit of Measure: weeks 10.7 (8.1 to 16.1)" ]

[ "Adverse Events 1:", " Total: 12/538 (2.23%)", " Hypertension 0/538 (0.00%)", " Acoustic Neuroma 1/538 (0.19%)", " Diarrhea 0/538 (0.00%)", " Colitis 1/538 (0.19%)", " Elevated ALT or AST enzyme 7/538 (1.30%)", " Diagnosis of Uterine Cancer 0/538 (0.00%)", " Motorcycle accident 0/538 (0.00%)", " Fall 0/538 (0.00%)", " Surgery 3/538 (0.56%)", "Adverse Events 2:", " Total: 8/537 (1.49%)", " Hypertension 1/537 (0.19%)", " Acoustic Neuroma 0/537 (0.00%)", " Diarrhea 1/537 (0.19%)", " Colitis 0/537 (0.00%)", " Elevated ALT or AST enzyme 0/537 (0.00%)", " Diagnosis of Uterine Cancer 2/537 (0.37%)", " Motorcycle accident 1/537 (0.19%)", " Fall 1/537 (0.19%)", " Surgery 2/537 (0.37%)" ]

[ "Adverse Events 1:", " Total: 6/15 (40.00%)", " diarrhea and dehydration * 0/15 (0.00%)", " Severe Dehydration * 1/15 (6.67%)", " hypokalemia * 1/15 (6.67%)", " pain, swelling, mastectomy site cellulitis * 0/15 (0.00%)", " death progressive disease * 0/15 (0.00%)", " divetricular abscess * 0/15 (0.00%)", " fever * 1/15 (6.67%)", " febrile neutropenia * 3/15 (20.00%)", " Neutropenia * 0/15 (0.00%)", "Adverse Events 2:", " Total: 4/14 (28.57%)", " diarrhea and dehydration * 0/14 (0.00%)", " Severe Dehydration * 0/14 (0.00%)", " hypokalemia * 0/14 (0.00%)", " pain, swelling, mastectomy site cellulitis * 0/14 (0.00%)", " death progressive disease * 1/14 (7.14%)", " divetricular abscess * 0/14 (0.00%)", " fever * 0/14 (0.00%)", " febrile neutropenia * 2/14 (14.29%)", " Neutropenia * 0/14 (0.00%)" ]

[ "Outcome Measurement: ", " Systemic Tumor Response Rates (Complete Response+Partial Response)", " The systemic tumor response refers to the response at the time of best overall response. The response criteria are specially adapted from Response Evaluation Criteria in Solid Tumor for Immunotherapies (Wolchok, et al., 2009).", " Time frame: 9 weeks from the start of the treatment of RT", "Results 1: ", " Arm/Group Title: IMQ+RT", " Arm/Group Description: This arm has been closed as of 6/4/2014.", " Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)", " Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied to all skin sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.", " Week 9: response assessment", " Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.", " Radiation", " Imiquimod", " Overall Number of Participants Analyzed: 12", " Measure Type: Number", " Unit of Measure: proportion of tumors .25 (.06 to .57)", "Results 2: ", " Arm/Group Title: CTX/IMQ/RT", " Arm/Group Description: Week -1 (day-7): cyclophosphamide 200mg/m2 IV as single infusion", " Weeks 1-2: RT given to one metastatic skin site at 6 Gy on days 1, 3, 5, 8 and 10 (M-W-F-M-W)", " Weeks 1-8: day 1-5 of each week: imiquimod 5% cream applied all sites overnight, starting on day 1 after RT, day 6-7 of each week: rest period.", " Week 9: response assessment", " Patients may continue to receive additional cycles (same schedule, RT given to a different site), provided that patients wish to continue, are without clinically significant progression and further treatment may be beneficial in the opinion of the investigator.", " Radiation", " Imiquimod", " Cyclophosphamide", " Overall Number of Participants Analyzed: 12", " Measure Type: Number", " Unit of Measure: proportion of tumors .083 (.002 to .38)" ]

[ "Outcome Measurement: ", " Time to Tumor Progression (TTP)", " Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).", " Time frame: Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks", "Results 1: ", " Arm/Group Title: Axitinib + Docetaxel (Phase 2, Double-blind)", " Arm/Group Description: Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.", " Overall Number of Participants Analyzed: 112", " Median (95% Confidence Interval)", " Unit of Measure: days 247 (208 to 265)", "Results 2: ", " Arm/Group Title: Docetaxel + Placebo (Phase 2, Double-blind)", " Arm/Group Description: Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.", " Overall Number of Participants Analyzed: 55", " Median (95% Confidence Interval)", " Unit of Measure: days 215 (191 to 247)" ]

[ "Outcome Measurement: ", " Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy", " Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)", " Time frame: 21 days (Cycle 1 of chemotherapy treatment)", "Results 1: ", " Arm/Group Title: EP2006 + EP2006 & Neupogen", " Arm/Group Description: All subjects randomized to receive either EP2006 in Cycle 1", " Overall Number of Participants Analyzed: 101", " Mean (Standard Deviation)", " Unit of Measure: Days 1.17 (1.11)", "Results 2: ", " Arm/Group Title: Neupogen + Neupogen & EP2006", " Arm/Group Description: All subjects randomized to receive Neupogen in Cycle 1", " Overall Number of Participants Analyzed: 103", " Mean (Standard Deviation)", " Unit of Measure: Days 1.2 (1.02)" ]

[ "Adverse Events 1:", " Total: 6", " Agranulocytosis 0/42 (0.00%)", " Anaemia 2/42 (4.76%)", " Febrile neutropenia 1/42 (2.38%)", " Leukopenia 0/42 (0.00%)", " Neutropenia 1/42 (2.38%)", " Thrombocytopenia 1/42 (2.38%)", " Cardio-respiratory arrest 0/42 (0.00%)", " Pericardial effusion 1/42 (2.38%)", " Gastric ulcer haemorrhage 0/42 (0.00%)", " Melaena 0/42 (0.00%)", " Fatigue 1/42 (2.38%)", " Multi-organ failure 0/42 (0.00%)", "Adverse Events 2:", " Total: 13", " Agranulocytosis 1/61 (1.64%)", " Anaemia 1/61 (1.64%)", " Febrile neutropenia 0/61 (0.00%)", " Leukopenia 2/61 (3.28%)", " Neutropenia 2/61 (3.28%)", " Thrombocytopenia 1/61 (1.64%)", " Cardio-respiratory arrest 1/61 (1.64%)", " Pericardial effusion 0/61 (0.00%)", " Gastric ulcer haemorrhage 1/61 (1.64%)", " Melaena 1/61 (1.64%)", " Fatigue 1/61 (1.64%)", " Multi-organ failure 1/61 (1.64%)" ]

[ "Adverse Events 1:", " Total: 17/145 (11.72%)", " ANAEMIA 0/145 (0.00%)", " LEUKOPENIA 2/145 (1.38%)", " NEUTROPENIA 1/145 (0.69%)", " LEUKOCYTOSIS 1/145 (0.69%)", " THROMBOCYTOPENIA 1/145 (0.69%)", " FEBRILE NEUTROPENIA 1/145 (0.69%)", " THROMBOTIC THROMBOCYTOPENIC PURPURA 0/145 (0.00%)", " DISSEMINATED INTRAVASCULAR COAGULATION 0/145 (0.00%)", " CARDIAC FAILURE 1/145 (0.69%)", " ATRIAL FIBRILLATION 1/145 (0.69%)", "Adverse Events 2:", " Total: 11/144 (7.64%)", " ANAEMIA 1/144 (0.69%)", " LEUKOPENIA 0/144 (0.00%)", " NEUTROPENIA 0/144 (0.00%)", " LEUKOCYTOSIS 0/144 (0.00%)", " THROMBOCYTOPENIA 0/144 (0.00%)", " FEBRILE NEUTROPENIA 1/144 (0.69%)", " THROMBOTIC THROMBOCYTOPENIC PURPURA 1/144 (0.69%)", " DISSEMINATED INTRAVASCULAR COAGULATION 1/144 (0.69%)", " CARDIAC FAILURE 0/144 (0.00%)", " ATRIAL FIBRILLATION 0/144 (0.00%)" ]

[ "INTERVENTION 1: ", " Letrozole and Imatinib Mesylate", " Imatinib mesylate 400 mg by mouth twice a day daily for 28 days and Letrozole 2.5 mg once a day daily for 28 days cycle." ]

[ "Inclusion Criteria:", " Estrogen receptor or progesterone receptor positive breast cancer", " Premenopausal with regular menstrual cycles", "Exclusion Criteria:", " Current oral contraceptives" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast carcinoma.", " Early stage breast cancer - stage I (tumor size greater than 1 cm), II and IIA.", " 3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity.", " Patients must have measurable disease as defined by palpable lesion with both diameters greater than or equal to 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension greater than or equal to 1 cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the patient registration form. To be valid for baseline, the measurements must have been made within the 14 days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study.", " ECOG performance status 0 to 2 within 14 days of study entry.", " Normal (greater than 50%) left ventricular ejection fraction (LVEF) by MUGA scan or echocardiography.", " Must be 18 years of age or older.", " Women or men of childbearing potential must use a reliable and appropriate contraceptive method. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.", " Final eligibility for a clinical trial is determined by the health professionals conducting the trial.", "Exclusion Criteria:", " Evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.", " Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. Patients with history of DCIS are eligible if they were treated with surgery alone.", " Medical, psychological, or surgical condition which the investigator feels might compromise study participation.", " Pregnant or lactating women are not eligible.", " Patients with history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.", " Evidence of sensory and/or peripheral neuropathy.", " Serious, uncontrolled, concurrent infections.", " Major surgery within 4 weeks of the start of study treatment without complete recovery.", " Final eligibility for a clinical trial is determined by the health professionals conducting the trial." ]