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nli4ct_semeval2024

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[ "Adverse Events 1:", " Total: 29/110 (26.36%)", " Atrial fibrillation 1/110 (0.91%)", " Nausea 2/110 (1.82%)", " Abdominal pain 1/110 (0.91%)", " Abdominal pain upper 1/110 (0.91%)", " Constipation 1/110 (0.91%)", " Pancreatitis 1/110 (0.91%)", " Vomiting 1/110 (0.91%)", " Pyrexia 3/110 (2.73%)", " Axillary pain 2/110 (1.82%)", " Chest pain 1/110 (0.91%)", " Influenza like illness 1/110 (0.91%)", "Adverse Events 2:", " " ]

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

[ "INTERVENTION 1: ", " Zr89-trastuzumab PET/CT", " Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm" ]

[ "INTERVENTION 1: ", " Trastuzumab/Ixabepilone/Carboplatin", " During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.", " After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity." ]

[ "Inclusion Criteria:", " Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.", " Tumors over-expressing Her-2", " Candidate for treatment with docetaxel/trastuzumab", "Exclusion Criteria:", " Histology of inflammatory carcinoma", " AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed stage IV breast cancer", " Metastasis to the ipsilateral supraclavicular lymph nodes allowed", " HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting", " No effusions or ascites as only sites of disease", " No primary or metastatic brain or central nervous system tumor", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age:", " 18 and over", " Sex:", " Female", " Menopausal status:", " Not specified", "Performance status:", " Zubrod 0-2", " Life expectancy:", " Not specified", " Hematopoietic:", " Absolute neutrophil count at least 1,500/mm^3", " Platelet count at least 100,000/mm^3", " Hepatic:", " Bilirubin normal", " aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN)", " Alkaline phosphatase no greater than 2.5 times ULN", " Renal:", " Not specified", " Cardiovascular:", " left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy)", " No clinical evidence or history of cardiomyopathy", " Other:", " No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer", " No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80", " No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer currently in complete remission", " No known sensitivity to E. coli-derived proteins", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " Not specified", " Chemotherapy:", " At least 6 months since prior chemotherapy", " Prior anthracycline as adjuvant therapy allowed", " No prior cumulative dose of doxorubicin more than 360 mg/m^2", " No prior cumulative dose of epirubicin more than 720 mg/m^2", " No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease", " No prior docetaxel", " No prior vinorelbine", " Prior paclitaxel allowed", " Endocrine therapy:", " Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed", " No concurrent hormonal therapy", " Radiotherapy:", " At least 3 weeks since prior radiotherapy", " Surgery:", " At least 2 weeks since prior surgery and recovered" ]

[ "INTERVENTION 1: ", " Arm I: Alkaline Water", " Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.", " alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.", " external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.", "INTERVENTION 2: ", " Arm II: Distilled Water", " Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy", " distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.", " external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks." ]

[ "Outcome Measurement: ", " Recurrence-free Survival", " Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease.", " Time frame: Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 years", "Results 1: ", " Arm/Group Title: Treatment (Chemotherapy With or Without Maintenance Therapy)", " Arm/Group Description: SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.", " MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.", " cyclophosphamide, paclitaxel, trastuzumab: Given IV", " Overall Number of Participants Analyzed: 100", " Measure Type: Number", " Unit of Measure: percentage of subjects 98 (92.2 to 99.5)" ]

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

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.", " Time frame: 24 Months, End of Study (Up to 5 years)", "Results 1: ", " Arm/Group Title: Trastuzumab + Anastrozole", " Arm/Group Description: Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.", " Overall Number of Participants Analyzed: 103", " Median (95% Confidence Interval)", " Unit of Measure: Months 24 Months: 4.8 (3.7 to 7)", " End of Study: 5.8 (4.6 to 8.3)", "Results 2: ", " Arm/Group Title: Anastrozole", " Arm/Group Description: 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.", " Overall Number of Participants Analyzed: 104", " Median (95% Confidence Interval)", " Unit of Measure: Months 24 Months: 2.4 (2 to 4.6)", " End of Study: 2.9 (2.1 to 4.5)" ]

[ "INTERVENTION 1: ", " Treatment (Enzyme Inhibitor Therapy)", " Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity." ]

[ "Inclusion Criteria:", " Female or male patient diagnosed with stage I-IV breast cancer", " HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) 2.0 on breast specimen or biopsy of a metastatic site", " LVEF < 50% and 40% documented in echocardiogram done within the last 30 days", " HER2 therapy naïve or currently receiving non-lapatinib HER2 targeted therapy", " Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation", " Age 18 years", " Patient is willing and able to comply with protocol required assessments and procedures", "Exclusion Criteria:", " Previous hospitalization due to documented heart failure in the last 12 months", " Current signs or symptoms of heart failure or ischemia", " History of arrhythmia requiring pharmacological or electrical treatment", " Concomitant use of anthracyclines or use of anthracyclines in the last 50 days", " Pregnant or lactating patients. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.", " History of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent." ]

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

[ "Inclusion Criteria:", " Female", " Age > 21 years", " Has diagnosis of non-recurrent stage I-III breast cancer", " Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)", " Has a partner or spouse who is > 21", " Lives with a romantic partner > 6 months", " Score of > 3 on Patient Care Monitor Sexual Concerns screening item", " No hearing impairment in patient or partner", "Exclusion Criteria:", " Not able to speak English, as stated in medical record or as observed by study team member", " ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record", " Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.", " Past history of any cancer other than non-melanoma skin cancer", " Currently participating in couple/marital therapy", "Currently pregnant" ]

[ "Inclusion Criteria:", " females, 18 or older", " recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer", " paraffin-embedded tissue block must be available", " measurable disease", " prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)", " 0, 1 or 2 chemotherapies in the metastatic setting", " adequate organ function", "Exclusion Criteria:", " Metastatic disease confined to bone only", " Symptomatic CNS metastasis", " Concurrent medical condition which may increase the risk of toxicity", " Unable to take oral medication" ]

[ "Adverse Events 1:", " Total: 8/56 (14.29%)", " Platelets * 1/56 (1.79%)", " Heart failure * 1/56 (1.79%)", " Left ventricular systolic dysfunction * 1/56 (1.79%)", " Dehydration * 1/56 (1.79%)", " Diarrhea * 1/56 (1.79%)", " Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) * 1/56 (1.79%)", " Sodium, serum-low (hyponatremia) * 1/56 (1.79%)", " Fracture * 2/56 (3.57%)" ]

[ "Adverse Events 1:", " Total: 18/70 (25.71%)", " Cardiac arrest 1/70 (1.43%)", " Pericardial effusion 1/70 (1.43%)", " Ear pain 1/70 (1.43%)", " Blurred vision 1/70 (1.43%)", " Eye disorders - Other, specify 2/70 (2.86%)", " Abdominal Pain 5/70 (7.14%)", " Colitis 1/70 (1.43%)", " Diarrhea 2/70 (2.86%)", " Nausea 2/70 (2.86%)", " Death NOS 1/70 (1.43%)", " Edema limbs 1/70 (1.43%)", " Fatigue 3/70 (4.29%)" ]

[ "INTERVENTION 1: ", " Tamoxifen or Letrozole", " tamoxifen or letrozole work in treating women with ductal carcinoma in situ", " letrozole", " tamoxifen citrate", " conventional surgery", " neoadjuvant therapy" ]

[ "Inclusion Criteria", " Subjects must be premenopausal and between the ages of 25 and 54 and must have had a menstrual period within the past 12 months. Women who are not menstruating regularly due to use of certain types of contraceptives may be entered with restrictions. Their estrogen progesterone, and follicle stimulating hormone (FSH) levels must be documented at baseline random periareolar fine needle aspiration (RPFNA) and their off study RPFNA must take place at a similar portion of their cycle (high or low progesterone levels). In order to do this a serum progesterone will have to be obtained ~ 4 weeks before planned RPFNA and again 2 weeks later such that the RPFNA can be performed in the same phase of the \"cycle\" as baseline.", " Subjects must be at increased risk for breast cancer on the basis of at least one of the following criteria:", " A five-year Gail risk of 1.67% or three times the average risk for a woman of the same age using either the Surveillance Epidemiology and End Results (SEER, http://seer.cancer.gov) database or the NCI Breast Cancer Risk Assessment Tool (www.cancer.gov/bcrisktool)., or 10 yr Tyrer-Cuzick risk twice that of the population risk as listed in model, or RPFNA atypia", " BMI <40 Kg/m3", " A first degree relative with breast cancer under the age of 60 or multiple second degree relatives with breast cancer.", " Multiple prior biopsies or at least one prior biopsy exhibiting atypical hyperplasia (AH), lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS).", " RPFNA evidence of hyperplasia with atypia within the last three years;", " Chest or neck radiation before age 30;", " Mammographic breast density by visual estimate equals or exceeds 50%.", " Subjects must be willing to continue the same hormonal milieu present at baseline throughout trial. If not using an oral, vaginal, or topical contraceptive, must be willing to actively use barrier methods of contraception to prevent pregnancy.", " Six months or more must have elapsed from completion of a prevention intervention trial (with exception of a weight reduction trial), ingestion of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) prior to baseline biomarker assessment.", " Subjects must be willing to undergo measurement of height, weight, and BMI and undergo body composite analysis (DEXA) at initiation and conclusion of intervention.", " Subjects with a history of AH, LCIS, or ER-positive DCIS by diagnostic biopsy, must have been counseled about appropriate standard prevention therapies such as tamoxifen and are either not eligible or are not interested in standard prevention therapies. Women with DCIS must have had appropriate local therapy (lumpectomy plus radiation or mastectomy). If subject has had a DCIS, at least two months must have elapsed from surgery and/or radiation therapy to the involved breast. Only the contralateral (uninvolved breast) will be studied by RPFNA. The subject may not have had any radiation therapy to the contralateral breast to be studied", " Subjects > 40 must have had a screening mammogram within 6 months of entering the interventional portion of the study and read as not suspicious for breast cancer or if suspicious must have completed all suggested tests including biopsy and found to have no evidence of cancer. Subjects of sufficient age and/or risk for a baseline mammogram must be willing to have an off-study mammogram performed 6 months after study entry.", " Subjects must have had an RPFNA of the breast within six months prior to entering the intervention portion of the study and be willing to have another RPFNA at ~6.5 months after starting Lovaza™.", "Tissue Eligibility: Subjects must have cytomorphologic evidence of hyperplasia with atypia or borderline atypia (Masood score 14 or higher). There must be 500 epithelial cells on the slide for cytomorphology and evidence of proliferation by Ki-67 staining. There must be sufficient reserved methanol- formalin-fixed material for real time quantitative polymerase chain reaction (RT-qPCR). Frozen tissue must also have been obtained for fatty acid analysis, reverse phase proteomics, adipokines and cytokines, and RT-qPCR.", " Subjects must be willing to undergo phlebotomy at baseline, and 6 months and 6.5 months approximately 3 tablespoons of blood will be obtained at baseline, and 6 months and 6.5 months or 6 tablespoons if the subject decides to participate in the optional monocyte cytokine release assay .", " Subjects must produce a spot urine sample at baseline, 6 months and at study conclusion. Baseline urine sample will in part be used to document that subject is not pregnant.", " Subjects must be willing to complete questionnaires regarding diet and supplement use, quality of life, relevant family history, personal health and reproductive history and medications at initiation and conclusion of the intervention.", " Subjects must be willing to sign an informed consent for the entire study and separate consent for repeat RPFNA", " Exclusion Criteria", " Women that have had a metastatic malignancy of any kind.", " Women that have had prior invasive breast cancer, diagnosed or treated within the past five years.", " Women who are currently taking anticoagulants.", " Women who have breast implants.", " Women who have undergone change in their hormonal milieu in the past 6 months this includes pregnancy, lactation, or stopping or starting hormonal contraceptives..", " Women who have taken omega 3 fatty acid supplements within 3 weeks prior to their baseline RPFNA.", " Women who regularly take NSAIDS (>7 tablets weekly).", " Inclusion of Women and Minorities", " -This study utilizes women at increased risk for breast cancer. Subjects recruited from an established cohort of women followed in the Breast Cancer Prevention Center. From previous trials we can expect 6% minority accrual which is similar to our hospital demographics. Males are not included due to the low absolute risk of breast cancer, and the difficulty of performing RPFNA on the male breast." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed stage IV breast cancer", " Metastasis to the ipsilateral supraclavicular lymph nodes allowed", " HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting", " No effusions or ascites as only sites of disease", " No primary or metastatic brain or central nervous system tumor", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age:", " 18 and over", " Sex:", " Female", " Menopausal status:", " Not specified", "Performance status:", " Zubrod 0-2", " Life expectancy:", " Not specified", " Hematopoietic:", " Absolute neutrophil count at least 1,500/mm^3", " Platelet count at least 100,000/mm^3", " Hepatic:", " Bilirubin normal", " aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN)", " Alkaline phosphatase no greater than 2.5 times ULN", " Renal:", " Not specified", " Cardiovascular:", " left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy)", " No clinical evidence or history of cardiomyopathy", " Other:", " No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer", " No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80", " No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer currently in complete remission", " No known sensitivity to E. coli-derived proteins", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " Not specified", " Chemotherapy:", " At least 6 months since prior chemotherapy", " Prior anthracycline as adjuvant therapy allowed", " No prior cumulative dose of doxorubicin more than 360 mg/m^2", " No prior cumulative dose of epirubicin more than 720 mg/m^2", " No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease", " No prior docetaxel", " No prior vinorelbine", " Prior paclitaxel allowed", " Endocrine therapy:", " Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed", " No concurrent hormonal therapy", " Radiotherapy:", " At least 3 weeks since prior radiotherapy", " Surgery:", " At least 2 weeks since prior surgery and recovered" ]

[ "Inclusion Criteria:", " Male and Female patients must be at least 18 years of age", " Pathologically confirmed diagnosis of breast cancer", " Metastatic or advanced stage breast cancer", " Prior treatment with at least one and no more than three lines of biologic and/or chemotherapy for metastatic breast cancer (excluding hormonal therapy)", " Patients with HER2+ disease must have received prior treatment with Trastuzumab", " Patients with ER and/or PR+ disease must have received prior treatment with hormonal therapy", " Off cytotoxic chemotherapy or biologic therapy (excluding Hormonal therapy) 3 weeks", " Measurable disease by RECIST 1.1", " Central nervous system metastases are permitted if treated and radiographically and clinically stable for at least 4 weeks prior to first dose of STA-9090", " Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1", " Life expectancy of at least 3 months", " Adequate hematologic function as defined by:", " Absolute neutrophil count 1,500 cells/μL", " Platelets 100,000/μL", " Hemoglobin 9.0g/dL", " Adequate hepatic function as defined by:", " Serum bilirubin 1.5 X upper limit of normal (ULN);", " Adequate renal function as defined by a serum creatinine 1.5 x ULN", " AST, ALT, and alkaline phosphatase 3 × ULN except for:", " Patients with hepatic metastases: ALT and AST 5 × ULN", " Patients with hepatic and/or bone metastases: alkaline phosphatase 5 × ULN", " Patients with Gilbert's disease: serum bilirubin < 5 mg/dL", " Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures", " Female subjects of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment", " Female subjects of childbearing age must have a negative serum pregnancy test at study entry.", "Exclusion Criteria:", " Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease", " Major surgery within 4 weeks prior to first dose of STA-9090", " Poor peripheral venous access for study drug administration. Study drug administration via indwelling catheters allowed only if the catheter is made of silicone material.", " History of severe (grade 3 or 4) allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol [PEG] 300 and Polysorbate 80)", " Baseline QTc > 470 msec", " Ventricular ejection fraction (EF) <50% at baseline", " Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)", " Women who are pregnant or lactating", " Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements", " Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigator", " Seizure disorder or requirement for seizure medication", " Prior treatment with an HSP90 inhibitor", " persistent adverse events of prior therapies that are > 1 grade 1 in severity", " history of or current coronary artery disease, myocardial infarction, angina pectoris, angioplasty or coronary bypass surgery", " history of or current uncontrolled dysrhythmias, or requirement for antiarrhythmic medications, or Grade 2 or greater left bundle branch block", " New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers or diuretics" ]

[ "INTERVENTION 1: ", " Pertuzumab + Trastuzumab + Taxane", " Participants received pertuzumab and trastuzumab intravenously (IV) plus taxane chemotherapy once of every 3 weeks per treatment cycle until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurred first. Taxane chemotherapy was docetaxel, paclitaxel, or nab-paclitaxel, per the investigator's choice." ]

[ "INTERVENTION 1: ", " Afatinib 50 mg", " Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.", "INTERVENTION 2: ", " Lapatinib 1500 mg", " Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial." ]

[ "INTERVENTION 1: ", " Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo", " Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).", "INTERVENTION 2: ", " Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg", " Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD." ]

[ "Inclusion Criteria:", " 18 years of age or older with written informed consent", " Scheduled for a modified radical mastectomy", " Surgical wound classified Class I/Clean using the CDC SSI Surgical Wound Classification", "Exclusion Criteria:", " Unable to give consent and unlikely to comply with study requirements and complete the 90-day follow up visit", " Undergoing surgery for modified radical mastectomy with immediate breast reconstruction, cosmetic breast operations, reduction, expansion, insertion of prothesis, duct ectasia or infective breast disease or implant", " Surgical wounds classified as Class II, III or IV using CDC SSI Surgical Wound Classification", " Has inflammatory cancers or skin ulceration", " Has known allergy or intolerance to triclosan", " Has compromised wound healing or chronic immune deficiency, for example diabetes, prolonged steroid use, AIDS or substance abuse", " Has serious heart and/or lung disease", " Has skin scar history or family history", " Has direct relationship to or involvement in this or other studies under the direction of the investigator or center", " Received an experimental drug or device within 30 days prior to the planned start of treatment" ]

[ "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" ]

[ "INTERVENTION 1: ", " AZD8931 160 mg bd", " Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle", "INTERVENTION 2: ", " AZD8931 120 mg bd", " Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle" ]

[ "Adverse Events 1:", " Total: 14/81 (17.28%)", " Neutropenia1/81 (1.23%)", " Cataract1/81 (1.23%)", " Ascites1/81 (1.23%)", " Gastritis Hemorrhagic1/81 (1.23%)", " Nausea1/81 (1.23%)", " Stomatitis2/81 (2.47%)", " Malaise1/81 (1.23%)", " Oedema1/81 (1.23%)", " Pain1/81 (1.23%)", " Pyrexia1/81 (1.23%)", " Infection2/81 (2.47%)", " Upper Limb Fracture1/81 (1.23%)", " Dehydration1/81 (1.23%)", " Hypercalcemia1/81 (1.23%)" ]

[ "Adverse Events 1:", " Total: 8/54 (14.81%)", " Anaemia 1/54 (1.85%)", " Febrile Neutropenia 1/54 (1.85%)", " Retinopathy Hypertensive 1/54 (1.85%)", " Febrile Infection 1/54 (1.85%)", " Postoperative Wound Complication 1/54 (1.85%)", " Cardiac Imaging Procedure Abnormal 1/54 (1.85%)", " Malignant Melanoma In Situ 1/54 (1.85%)", " Suicide Attempt 1/54 (1.85%)", " Dyspnoea 1/54 (1.85%)" ]

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

[ "Outcome Measurement: ", " Percent Change (Between Baseline and Month 12) in Mammographic Density by the Boyd Method Compared Between Arms", " To evaluate change in mammographic density using the Boyd method after one year of vitamin D supplementation compared to placebo in premenopausal women. The percent change in breast density will be reported here.", " Time frame: 12 months", "Results 1: ", " Arm/Group Title: Placebo", " Arm/Group Description: Patients receive oral placebo once daily for 12 months.", " Overall Number of Participants Analyzed: 46", " Mean (Standard Deviation)", " Unit of Measure: percent change -3.4 (7.1)", "Results 2: ", " Arm/Group Title: Vitamin D", " Arm/Group Description: Patients receive oral vitamin D (2000 IU) once daily for 12 months.", " Overall Number of Participants Analyzed: 40", " Mean (Standard Deviation)", " Unit of Measure: percent change -1.4 (11.9)" ]

[ "INTERVENTION 1: ", " Letrozole", " Letrozole, 2.5 mg daily for six months" ]

[ "INTERVENTION 1: ", " Celecoxib", " Randomized to receive celecoxib daily for 12 months", "INTERVENTION 2: ", " Placebo", " Randomized to receive placebo daily for 12 months" ]

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

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

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

[ "Inclusion Criteria:", " Recurrent or residual metastatic breast carcinoma", " Zubrod performance status less than 2", " 18-60 years old", " Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.", " No major organ dysfunction or active infection", "Exclusion Criteria: None" ]

[ "Inclusion Criteria:", " Patient must be postmenopausal defined as meeting one or more of the following:", " Age 60 years", " Amenorrheic for at least 12 months", " Surgically sterile- having undergone bilateral oophorectomy,", " FSH level in postmenopausal range according to institutional standards (note follicle-stimulating hormone (FSH) laboratory testing must be ordered as standard of care to determine optimal treatment and should not be ordered simply to confirm eligibility to this study)", " OR Pre-menopausal for whom standard estradiol treatment (ET) is planned with ovarian suppression (imaging on study should be completed prior to start of ovarian suppression)", " Patient must have histological or cytological confirmed breast cancer and fall into one of the following categories:", " New diagnosis with plans for at least 6 months of neoadjuvant ET or any amount of neoadjuvant ET if surgery is planned as this will be used for response assessment .", " Patients with newly diagnosed metastatic breast cancer or patient with known metastatic disease who has progressed while on therapy (no washout period is needed if the patient was treated with AIs or chemotherapy, but 2 months washout period is needed if the patient was treated with tamoxifen) who are going to be treated with ET.", " Patient must have any one of the following types of breast cancer (primary or metastatic): ER+/PgR+/HER2- or ER+/PgR-/HER2-.", " ER+ is defined as Allred score of at least 4 and greater.", " PgR+ is defined as Allred score of at least 4 and greater.", " Immunohistochemistry (IHC) is the primary assay methodology for HER2. HER2- refers to HER2 of 0, 1+ by IHC or negative by fluorescence in situ hybridization (FISH)", " Patient must have at least one measurable lesion according to RECIST 1.1 by radiological evaluation (ultrasound, mammography, MRI, CT, PET) or physical examination.", " Patients with evaluable osseous metastasis that are lytic or mixed lytic-sclerotic are eligible.", " Patients with hepatic lesions may be eligible provided the location of the lesion is peripheral or not too close to hepatic ducts. Decision on hepatic lesion eligibility will be made by the principal investigator or sub-investigator after careful review of all available imaging to ensure evaluation of the lesion will not be obscured by normal hepatobiliary excretion of 18F-FFNP.", " Patient must be able to understand and willing to sign a written informed consent document.", " Prior chemotherapy or endocrine therapy is allowed", " The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or, based on the judgment of the treating medical oncologist, can tolerate imaging and at least 6 months of ET", " The patient should have a life expectancy of > 6 months.", "Exclusion Criteria:", " Patient with other invasive malignancies, with the exception of non-melanoma skin cancer or cervical carcinoma in-situ, who had (or have) any evidence of the other cancer present within the last 5 years", " Unable to tolerate up to 60 min of PET imaging per imaging session.", " Patients with non-measurable non-evaluable lesions such as pleural effusion are not eligible to participate.", " Patients with vertebral lesions that, in the opinion of the Principal Investigator and the treating medical oncologist, pose an imminent risk for cord compression." ]

[ "Inclusion Criteria:", " Histologically documented, incurable, locally advanced or metastatic breast cancer", " Evaluable or measurable HER2-positive disease", " History of progression during or within 60 days after treatment with any prior trastuzumab-containing chemotherapy regimen for HER2-positive breast cancer", " Previous treatment with chemotherapy for MBC", " Granulocyte count 1,500/μL, platelet count 100,000/μL, and hemoglobin 9 g/dL", " Serum bilirubin 1.5 mg/dL; AST, ALT, and alkaline phosphatase 2.5 × upper limit of normal (ULN) except for: Patients with hepatic metastases: ALT and AST 5 × ULN Patients with hepatic and/or bone metastases: alkaline phosphatase 5 × ULN", " Serum creatinine 1.5 mg/dL or creatinine clearance of 60 mL/min based on a 24-hour urine collection", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2", " Women of childbearing potential and men must agree to use an effective method of birth control (e.g., hormonal, barrier) while receiving study treatment", "Exclusion Criteria:", " History of significant cardiac disease, unstable angina, CHF, myocardial infarction, or ventricular arrhythmia requiring medication", " History of Grade 3 hypersensitivity reaction to trastuzumab", " History of any toxicity to trastuzumab that resulted in trastuzumab being permanently discontinued", " Symptomatic brain metastases or any radiation or surgery for brain metastases within 3 months of first study treatment", " Require supplemental oxygen for daily activities", " Grade 2 peripheral neuropathy", " Bisphosphonate therapy for symptomatic hypercalcemia", " Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 4 weeks of first study treatment", " Any experimental therapy within 4 weeks of first study treatment", " Any major surgical procedure within 4 weeks of first study treatment", " History of clinically symptomatic liver disease, including viral or other hepatitis, current or history of alcoholism, or cirrhosis", " Pregnancy or lactation", " Cardiac troponin I 0.2 ng/mL", " Ejection fraction < 50% or below the lower limit of normal determined by echocardiogram or MUGA scan", " Prior cumulative doxorubicin dose of > 360 mg/m2 or equivalent" ]

[ "INTERVENTION 1: ", " Prone to Supine MRI Evaluated by Radiologist A", " Radiologist A, number of participants successfully segmented", "INTERVENTION 2: ", " Prone to Supine MRI Evaluated by Radiologist B", " Radiologist B, number of participants successfully segmented" ]

[ "INTERVENTION 1: ", " Physical Activity Intervention", " Participants will participate in a multi-component physical activity intervention for 12 weeks with a 6 month follow up.", " Print-based education: Subjects were given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.", " Fitbit: Subjects were provided with a Fitbit and instructed to wear the device daily.", " Active Living counseling: The Active Living counseling program consists of 12 weekly group educational sessions. These sessions involved discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.", " Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.)." ]

[ "INTERVENTION 1: ", " AlloDerm RTU", " Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.", "AlloDerm RTU", "INTERVENTION 2: ", " SurgiMend PRS", " Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.", "SurgiMend PRS" ]

[ "Inclusion Criteria:", " Assigned female at birth;", " 18 years and older;", " Confirmed diagnosis (via biopsy) of early stage breast cancer (stages I-IIIA);", " Eligible for both breast-conserving surgery and mastectomy based on medical records and clinician's opinion before surgery;", " Spoken English, Spanish, or Mandarin Chinese.", "Exclusion Criteria:", " Transgender men and women;", " Women who have undergone prophylactic mastectomy;", " Women with visual impairment;", " Women with a diagnosis of severe mental illness or severe dementia;", " Women with inflammatory breast carcinoma." ]

[ "Inclusion Criteria:", " Written informed consent.", " Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days.", " Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinomas in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.", " Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: TNM pathologic stage N1a, TNM pathologic stage N2a, TNM pathologic stage N3a.", " Status of hormone receptors in primary tumour. Results must be available before the end of adjuvant chemotherapy.", " Patients must not present evidence of metastatic disease. Status of HER2 in primary tumour, known before randomization. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescence 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 >= 100 x 10^9/l; hemoglobin >= 10 mg/dl;", " Hepatic function: total bilirubin <= 1 upper normal limit (UNL); serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible;", " Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min;", " Pharmacogenetics: one blood sample is needed for single nucleotide polymorphism (SNP) assessment.", " Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week 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 prior 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.", " Any T4 or M1 tumour.", " Axillary lymph nodes: patients belonging to the following classifications are excluded: TNM pathologic stage N1b, TNM pathologic stage N1c, TNM pathologic stage N2b, TNM pathologic stage N3b, TNM pathologic stage N3c.", " HER2 positive breast cancer (IHC 3+ or positive FISH result).", " Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [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 from 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 tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.", " Chronic treatment with corticosteroids.", " Contraindications for corticosteroid administration.", " Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.", " 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 another therapy for cancer.", "Males." ]

[ "Adverse Events 1:", " Total: 1/4 (25.00%)", " Vertigo 0/4 (0.00%)", " Abdominal adhesions 0/4 (0.00%)", " Abdominal distension 0/4 (0.00%)", " Abdominal pain 0/4 (0.00%)", " Diarrhoea 0/4 (0.00%)", " Nausea 0/4 (0.00%)", " Vomiting 0/4 (0.00%)", " Disease progression 0/4 (0.00%)", " Influenza 0/4 (0.00%)", " Nasopharyngitis 0/4 (0.00%)", " Lumbar vertebral fracture 0/4 (0.00%)", " Hyponatraemia 0/4 (0.00%)", " Ataxia 0/4 (0.00%)" ]

[ "Adverse Events 1:", " Total: 24/101 (23.76%)", " LYMPHADENOPATHY 0/101 (0.00%)", " FEBRILE NEUTROPENIA 20/101 (0.00%)", " ATRIAL FIBRILLATION 1/101 (0.99%)", " ARRHYTHMIA 20/101 (0.00%)", " CARDIAC FAILURE 22/101 (1.98%)", " CARDIAC FAILURE CONGESTIVE 20/101 (0.00%)", " CORONARY OSTIAL STENOSIS 20/101 (0.00%)", " LACRIMAL DISORDER 0/101 (0.00%)", " BLINDNESS 21/101 (0.99%)", " GASTRIC ULCER 1/101 (0.99%)", " NAUSEA 1/101 (0.99%)", "Adverse Events 2:", " Total: 22/103 (21.36%)", " LYMPHADENOPATHY 1/103 (0.97%)", " FEBRILE NEUTROPENIA 21/103 (0.97%)", " ATRIAL FIBRILLATION 1/103 (0.97%)", " ARRHYTHMIA 21/103 (0.97%)", " CARDIAC FAILURE 20/103 (0.00%)", " CARDIAC FAILURE CONGESTIVE 21/103 (0.97%)", " CORONARY OSTIAL STENOSIS 21/103 (0.97%)", " LACRIMAL DISORDER 1/103 (0.97%)", " BLINDNESS 20/103 (0.00%)", " GASTRIC ULCER 0/103 (0.00%)", " NAUSEA 0/103 (0.00%)" ]

[ "INCLUSION CRITERIA:", " Patient must be 18 years of age or older", " Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast any T, any N, M0 disease", " Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of local surgery must be negative greater or equal to 2mm for both invasive carcinoma and for non-invasive ductal carcinoma Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question cannot be improved.", " Patients must be registered such that radiation therapy begins within 10 weeks of last surgery", " Patients must have a performance status 0 or 1 by Eastern Cooperative Oncology Group (ECOG) criteria or a 80-100 Karnofsky Performance Scale at time of consult", " Women of all races and ethnic groups are eligible for this trial", "EXCLUSION CRITERIA:", " Patients must not have received prior radiation therapy to the breast at any time for any reason", " Patients with squamous carcinomas or sarcomas of the breast cancer are not eligible", " Patients treated with a mastectomy are NOT eligible", " Any patient with active local-regional disease prior to registration is not eligible", " No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for at least 5 years", " Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy", " Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment" ]

[ "Adverse Events 1:", " Total: 6/62 (9.68%)", " Musculoskeletal * 1/62 (1.61%)", " Mood Alteration: Depression * 1/62 (1.61%)", " renal - Other * 1/62 (1.61%)", " Obstruction, GU: Uterus * 1/62 (1.61%)", " Sexual * 0/62 (0.00%)", " Pulmonary/Upper Respiratory: Dyspnea * 1/62 (1.61%)", " Ulceration * 1/62 (1.61%)", "Adverse Events 2:", " Total: 1/64 (1.56%)", " Musculoskeletal * 0/64 (0.00%)", " Mood Alteration: Depression * 0/64 (0.00%)", " renal - Other * 0/64 (0.00%)", " Obstruction, GU: Uterus * 0/64 (0.00%)", " Sexual * 1/64 (1.56%)", " Pulmonary/Upper Respiratory: Dyspnea * 0/64 (0.00%)", " Ulceration * 0/64 (0.00%)" ]

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

[ "INTERVENTION 1: ", " Standard Chemotherapy", " Patients receive cyclophosphamide-containing chemotherapy alone.", " cyclophosphamide: Part of planned chemotherapy regimen", "INTERVENTION 2: ", " Chemotherapy Plus Goserelin", " Patients receive goserelin subcutaneously once every 4 weeks beginning 1 week before start of cyclophosphamide-containing chemotherapy. Treatment continues until completion of chemotherapy in the absence of disease progression or unacceptable toxicity.", " cyclophosphamide: Part of planned chemotherapy regimen", " goserelin acetate: Given subcutaneously" ]

[ "INTERVENTION 1: ", " PD-0332991 100 mg: Dose Escalation Cohort", " In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.", "INTERVENTION 2: ", " PD-0332991 125 mg: Dose Escalation Cohort", " In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent." ]

[ "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)" ]

[ "Adverse Events 1:", " Total: 13/61 (21.31%)", " Anaemia 1/61 (1.64%)", " Febrile neutropenia 1/61 (1.64%)", " Cardiac failure congestive 0/61 (0.00%)", " Pericardial effusion 0/61 (0.00%)", " Constipation 1/61 (1.64%)", " Intestinal perforation 1/61 (1.64%)", " Stomatitis 0/61 (0.00%)", " Non-cardiac chest pain 2/61 (3.28%)", " Condition aggravated 1/61 (1.64%)", " General physical health deterioration 1/61 (1.64%)", "Adverse Events 2:", " Total: 12/60 (20.00%)", " Anaemia 1/60 (1.67%)", " Febrile neutropenia 0/60 (0.00%)", " Cardiac failure congestive 1/60 (1.67%)", " Pericardial effusion 1/60 (1.67%)", " Constipation 0/60 (0.00%)", " Intestinal perforation 0/60 (0.00%)", " Stomatitis 1/60 (1.67%)", " Non-cardiac chest pain 0/60 (0.00%)", " Condition aggravated 0/60 (0.00%)", " General physical health deterioration 1/60 (1.67%)" ]

[ "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." ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " Tumor response evaluation was performed using RECIST 1.0 using CT/MRI. Proportion of patients achieving a CR or PR is considered in the overall response.", " Time frame: Assessed at the end of each even-numbered cycle (every 8 weeks), or per standard of care but no less than 4 weeks and nor more than every 12 weeks (+/- 1 week) if treatment has ended.", "Results 1: ", " Arm/Group Title: Pralatrexate", " Arm/Group Description: Study drug 190 mg/m^2 for 2 to 4 weeks.", " Overall Number of Participants Analyzed: 22", " Measure Type: Number", " Unit of Measure: participants 1" ]

[ "Outcome Measurement: ", " Best Overall Response (BOR)", " Percentage of participants with best overall (objective) response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).", " Time frame: Evaluations were performed every 6 weeks until progression reported between day of first participant randomized, 20 June 2007, until cut-off date, 31 July 2009", "Results 1: ", " Arm/Group Title: Cisplatin and Cetuximab", " Arm/Group Description: Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.", " Overall Number of Participants Analyzed: 115", " Measure Type: Number", " Unit of Measure: percentage of participants 20.0 (13.1 to 28.5)", "Results 2: ", " Arm/Group Title: Cisplatin", " Arm/Group Description: Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.", " Overall Number of Participants Analyzed: 58", " Measure Type: Number", " Unit of Measure: percentage of participants 10.3 (3.9 to 21.2)" ]

[ "INTERVENTION 1: ", " Cohort B", " Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd" ]

[ "Adverse Events 1:", " Total: 331/1634 (20.26%)", " Anemia 3/1634 (0.18%)", " Coagulation disorders 1/1634 (0.06%)", " Hemorrhage Vaginal 1/1634 (0.06%)", " Leukopenia 18/1634 (1.10%)", " Lymphadenopathy 0/1634 (0.00%)", " Lymphedema 0/1634 (0.00%)", " Pancytopenia 0/1634 (0.00%)", " Thrombocytopenia 0/1634 (0.00%)", " Arrhythmia 3/1634 (0.18%)", " Arrhythmia Ventricular 0/1634 (0.00%)", " Cardiomyopathy 1/1634 (0.06%)", "Adverse Events 2:", " Total: 520/1635 (31.80%)", " Anemia 5/1635 (0.31%)", " Coagulation disorders 0/1635 (0.00%)", " Hemorrhage Vaginal 0/1635 (0.00%)", " Leukopenia 56/1635 (3.43%)", " Lymphadenopathy 1/1635 (0.06%)", " Lymphedema 2/1635 (0.12%)", " Pancytopenia 1/1635 (0.06%)", " Thrombocytopenia 1/1635 (0.06%)", " Arrhythmia 3/1635 (0.18%)", " Arrhythmia Ventricular 1/1635 (0.06%)", " Cardiomyopathy 0/1635 (0.00%)" ]

[ "Adverse Events 1:", " Total: 69/258 (26.74%)", " Anaemia 3/258 (1.16%)", " Febrile neutropenia 13/258 (5.04%)", " Neutropenia 5/258 (1.94%)", " Thrombocytopenia 1/258 (0.39%)", " Atrial fibrillation 0/258 (0.00%)", " Mitral valve incompetence 1/258 (0.39%)", " Pericardial effusion 0/258 (0.00%)", " Sinus tachycardia 0/258 (0.00%)", " Abdominal pain 3/258 (1.16%)", " Abdominal pain upper 1/258 (0.39%)", " Colitis 1/258 (0.39%)", "Adverse Events 2:", " Total: 64/224 (28.57%)", " Anaemia 2/224 (0.89%)", " Febrile neutropenia 4/224 (1.79%)", " Neutropenia 1/224 (0.45%)", " Thrombocytopenia 0/224 (0.00%)", " Atrial fibrillation 1/224 (0.45%)", " Mitral valve incompetence 0/224 (0.00%)", " Pericardial effusion 2/224 (0.89%)", " Sinus tachycardia 1/224 (0.45%)", " Abdominal pain 3/224 (1.34%)", " Abdominal pain upper 0/224 (0.00%)", " Colitis 0/224 (0.00%)" ]

[ "Adverse Events 1:", " Total: 14/41 (34.15%)", " Cardiac ischemia/infarction 2/41 (4.88%)", " Duodenal ulcer 1/41 (2.44%)", " Vomiting 2/41 (4.88%)", " Fever 2/41 (4.88%)", " Death NOS 1/41 (2.44%)", " Liver failure 1/41 (2.44%)", " Infection - pneumonia 2/41 (4.88%)", " Infection - port site 2/41 (4.88%)", " Infection - urinary tract 1/41 (2.44%)", " Disease progression 3/41 (7.32%)", " Confusion 1/41 (2.44%)" ]

[ "Inclusion Criteria", " Women > 18 years of age with histologically or cytologically confirmed stage I, II or III breast cancer.", " If adjuvant chemotherapy is recommended, it must be completed before study start.", " Bone marrow aspirate positive by IC/FC assay", " a. Definition of positive: > 4 MM/ml b. Timing of bone marrow aspiration to determine study eligibility: i. If patient is to receive either no adjuvant therapy or hormonal therapy alone, the aspiration may be performed at diagnosis as part of the large MM study at University of California, San Francisco, or following diagnosis if the patient received initial surgery elsewhere. This is also true for patients who have surgery following neoadjuvant therapy for breast cancer.", " ii. If the patient is to receive adjuvant chemotherapy, the aspiration will be performed at least three weeks after chemotherapy has been completed.", " Adequate renal function as defined by:", " a. Creatinine must be < upper limit of normal", " Normal liver function tests including total bilirubin, alkaline phosphatase, and aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)", " Ability to understand and sign informed consent.", " Concomitant hormonal therapy is allowed", " Concomitant radiation therapy is allowed", " Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy are eligible to participate in this trial", " Exclusion Criteria", " History of allergy to bisphosphonates. Acute phase reactions occur in up to 24% of patients and disappear with subsequent dosing. An acute phase reaction does not qualify as an allergic reaction.", " History of renal insufficiency. Renal insufficiency is defined by a serum creatinine greater than the upper limit of normal or a creatinine clearance < 50 mL/min due to any underlying cause.", " Karnofsky Performance status < 90%.", " Any significant medical condition that might interfere with treatment.", " Women participating in this study are not allowed to receive other bisphosphonate therapy during the study period, either oral or intravenous.", " Patients who are pregnant" ]

[ "Outcome Measurement: ", " Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4", " Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.", " Time frame: Baseline to Week 4", "Results 1: ", " Arm/Group Title: AZD0530 175 mg", " Arm/Group Description: AZD0530 (saracatinib) 175 mg once daily", " Overall Number of Participants Analyzed: 46", " Geometric Mean (95% Confidence Interval)", " Unit of Measure: Percentage change in betaCTX -71.1 (-75.9 to -65.4)", "Results 2: ", " Arm/Group Title: Zoledronic Acid 4 mg", " Arm/Group Description: Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period", " Overall Number of Participants Analyzed: 65", " Geometric Mean (95% Confidence Interval)", " Unit of Measure: Percentage change in betaCTX -68.4 (-73.0 to -63.2)" ]

[ "Adverse Events 1:", " Total: 32/106 (30.19%)", " Febrile neutropenia * 6/106 (5.66%)", " Leukopenia * 1/106 (0.94%)", " Neutropenia * 1/106 (0.94%)", " Arrhythmia * 1/106 (0.94%)", " Atrial fibrillation * 0/106 (0.00%)", " Cardiac failure * 0/106 (0.00%)", " Left ventricular dysfunction * 1/106 (0.94%)", " Myocardial infarction * 1/106 (0.94%)", " Supraventricular tachycardia * 0/106 (0.00%)", " Tachycardia * 0/106 (0.00%)", "Adverse Events 2:", " Total: 44/107 (41.12%)", " Febrile neutropenia * 3/107 (2.80%)", " Leukopenia * 0/107 (0.00%)", " Neutropenia * 3/107 (2.80%)", " Arrhythmia * 0/107 (0.00%)", " Atrial fibrillation * 1/107 (0.93%)", " Cardiac failure * 1/107 (0.93%)", " Left ventricular dysfunction * 0/107 (0.00%)", " Myocardial infarction * 0/107 (0.00%)", " Supraventricular tachycardia * 1/107 (0.93%)", " Tachycardia * 1/107 (0.93%)" ]

[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1", " DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.", " Time frame: Lead-in period (Day -7) up to Day 28 (Cycle 1)", "Results 1: ", " Arm/Group Title: PD-0332991 100 mg: Dose Escalation Cohort", " Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%", "Results 2: ", " Arm/Group Title: PD-0332991 125 mg: Dose Escalation Cohort", " Arm/Group Description: In Phase 1-Part 1, participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.", " Overall Number of Participants Analyzed: 6", " Measure Type: Count of Participants", " Unit of Measure: Participants 1 16.7%" ]

[ "Inclusion Criteria:", " Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.", " ER positive.", " The patient must be postmenopausal woman.", " The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).", "Exclusion Criteria:", " Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.", " Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®)." ]

[ "INCLUSION CRITERIA", " Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive", " Premenopausal, defined as any of:", " Last menstrual period within 3 months, or", " Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,", " If tamoxifen administered within the past 3 months, plasma estradiol must be in the premenopausal range", " Either positive estrogen and/or progesterone receptor determination by Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen.", " Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2", " Granulocytes > 1500/mm^3", " Platelets > 100,000/mm^3", " Serum glutamic oxaloacetic transaminase (SGOT) < 2.5 x upper limit of normal", " Total bilirubin < 1.5 mg/dL", " May have received irradiation to bony sites of disease for pain control or for prevention of fracture. The irradiated site(s) will NOT be evaluable for disease response.", " Must be using effective contraception or not be of childbearing potential", " Signed written informed consent", " INCLUSION CRITERIA", " Active, unresolved infection", " Active malignancy other than breast cancer, in situ carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years", " Prior treatment with an aromatase inhibitor or inactivator", " Prior treatment with an luteinizing hormone-releasing hormone (LH/RH) agonist/antagonist", " Adjuvant chemotherapy within 6 months of study entry.", " Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment", " Central nervous system metastasis", " Lymphangitic pulmonary metastasis", " Pregnant or lactating" ]

[ "INTERVENTION 1: ", " FSFI Total Score (Pretest)", " Administered to participants prior to starting vaginal testosterone therapy.", "INTERVENTION 2: ", " FSFI Total Score (Postteset)", " Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days)." ]

[ "INTERVENTION 1: ", " FEC-75 Then Paclitaxel/Trastuzumab", " Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies", "INTERVENTION 2: ", " Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75", " Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies" ]

[ "Adverse Events 1:", " Total: 10/48 (20.83%)", " NEUTROPENIA 1/48 (2.08%)", " THROMBOCYTOPENIA 0/48 (0.00%)", " VOLUME BLOOD DECREASED 1/48 (2.08%)", " FIBRILLATION ATRIAL 1/48 (2.08%)", " HYPOTENSION 1/48 (2.08%)", " ABDOMINAL PAIN 1/48 (2.08%)", " APPETITE DECREASED 0/48 (0.00%)", " DEHYDRATION 4/48 (8.33%)", " DIARRHEA 4/48 (8.33%)", " NAUSEA 3/48 (6.25%)", " VOMITING 2/48 (4.17%)", " FEVER 1/48 (2.08%)", " RIGORS 0/48 (0.00%)", "Adverse Events 2:", " Total: 5/53 (9.43%)", " NEUTROPENIA 1/53 (1.89%)", " THROMBOCYTOPENIA 1/53 (1.89%)", " VOLUME BLOOD DECREASED 0/53 (0.00%)", " FIBRILLATION ATRIAL 0/53 (0.00%)", " HYPOTENSION 0/53 (0.00%)", " ABDOMINAL PAIN 0/53 (0.00%)", " APPETITE DECREASED 1/53 (1.89%)", " DEHYDRATION 0/53 (0.00%)", " DIARRHEA 0/53 (0.00%)", " NAUSEA 1/53 (1.89%)", " VOMITING 1/53 (1.89%)", " FEVER 1/53 (1.89%)", " RIGORS 1/53 (1.89%)" ]

[ "Adverse Events 1:", " Total: 6/62 (9.68%)", " Musculoskeletal * 1/62 (1.61%)", " Mood Alteration: Depression * 1/62 (1.61%)", " renal - Other * 1/62 (1.61%)", " Obstruction, GU: Uterus * 1/62 (1.61%)", " Sexual * 0/62 (0.00%)", " Pulmonary/Upper Respiratory: Dyspnea * 1/62 (1.61%)", " Ulceration * 1/62 (1.61%)", "Adverse Events 2:", " Total: 1/64 (1.56%)", " Musculoskeletal * 0/64 (0.00%)", " Mood Alteration: Depression * 0/64 (0.00%)", " renal - Other * 0/64 (0.00%)", " Obstruction, GU: Uterus * 0/64 (0.00%)", " Sexual * 1/64 (1.56%)", " Pulmonary/Upper Respiratory: Dyspnea * 0/64 (0.00%)", " Ulceration * 0/64 (0.00%)" ]

[ "Inclusion Criteria:", " The patient is capable to understand and comply with the protocol and has signed the informed consent document.", " Females with histologically confirmed advanced breast cancer.", " TN breast cancer by local laboratory determination. Hormonal Receptor (HR) negative defined as < 1% positive cells by Immunohistochemistry (IHC) for both Estrogen Receptor (ER) and Progesterone Receptor (PgR), and HER2 negative defined as in situ hybridization (ISH) negative or IHC 0 or 1+ in the absence of ISH (Note: patients with IHC 2+ must have an ISH determination in order to confirm the HER2 negativity.", " Measurable or non-measurable disease according to RECIST 1.1 criteria.", " Patient is at least 18 years of age.", " World Health Organization (WHO) Performance Status 1.", " Life expectancy 12 weeks.", " Common laboratory values within normal range (…)", " A negative serum pregnancy test 72 hours before starting study treatment for pre-menopausal women and for women < 1 year from the last menstruation date.", "Exclusion Criteria:", " Have received more than 3 prior chemotherapy regimens for ABC.", " Patients with untreated brain metastases. However, a patient with Central Nervous System (CNS) metastases may participate in this trial if > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable with respect to the tumor at the time of study entry and is not receiving corticosteroid therapy.", " Patients with acute or chronic liver or renal disease or pancreatitis.", " Patients with a second primary malignancy that is clinically detectable at the time of consideration for study enrollment.", " Patients unable to swallow tablets.", " History of a positive HIV test (HIV testing is not mandatory).", " History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (Hepatitis B or C testing is not mandatory).", " Impairment of gastrointestinal (GI) function or GI disease (e.g. ulcerative disease, uncontrolled nausea, vomiting, grade 2 diarrhea, malabsorption syndrome or small bowel resection).", " Peripheral vascular disease requiring active therapy or having had surgery < 12 months prior to starting study drug.", " Impaired cardiac function or clinically significant heart disease (…)", " A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndrome", " Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)", " Patients who are receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5 (listed in Protocol Attachment 3) or drugs metabolized by CYP2B6 or CYP2C9 (listed in Protocol Attachment 3) that cannot be discontinued prior to study entry and for the duration of the study. Medications that are strong CYP3A4/5 inhibitors should be discontinued for at least 2 days, and strong CYP3A4/5 inducers for at least 1 week prior to initiating LDE225 dosing.", " Patients who have received chemotherapy within a period of time that is < the cycle length used for that treatment (e.g. < 3 weeks for fluorouracil, doxorubicine, epirubicin) prior to starting study drug or who have not recovered from the side effects of such therapy.", " Patients who have received biologic therapy (e.g. antibodies) 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy.", " Patients who have been treated with a small molecule therapeutic 5 t1/2 or 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.", " Patients who have received any other investigational agents 5 t1/2 or 4 weeks (whichever is shorter) prior to starting study drug or who have not recovered from the side effects of such therapy.", " Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) 4 weeks or limited field radiation for palliation 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.", " Patients who are currently receiving treatment with therapeutic doses of warfarin sodium (Coumadin) who cannot discontinue this treatment at least 5 days prior to starting study drug.", " Patients who are currently receiving immunosuppressive treatment and in whom the treatment cannot be discontinued prior to starting study drug, except in the case of patients with basal cell carcinoma (BCC). Immunosuppressive treatment should be discontinued for at least 1 week prior to initiating LDE225 dosing.", "…" ]

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

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

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

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

[ "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%)" ]

[ "Adverse Events 1:", " Total: 14/76 (18.42%)", " Neutropenia 10/76 (13.16%)", " Febrile neutropenia 1/76 (1.32%)", " Anaemia 0/76 (0.00%)", " Thrombocytopenia 0/76 (0.00%)", " Cardiopulmonary failure 0/76 (0.00%)", " Optic ischaemic neuropathy 0/76 (0.00%)", " Bowel peristalsis increased 1/76 (1.32%)", " Colitis 0/76 (0.00%)", " Diarrhoea 0/76 (0.00%)", " Gastritis 0/76 (0.00%)", " Nausea 0/76 (0.00%)", "Adverse Events 2:", " Total: 12/76 (15.79%)", " Neutropenia 2/76 (2.63%)", " Febrile neutropenia 1/76 (1.32%)", " Anaemia 0/76 (0.00%)", " Thrombocytopenia 0/76 (0.00%)", " Cardiopulmonary failure 1/76 (1.32%)", " Optic ischaemic neuropathy 1/76 (1.32%)", " Bowel peristalsis increased 0/76 (0.00%)", " Colitis 1/76 (1.32%)", " Diarrhoea 0/76 (0.00%)", " Gastritis 0/76 (0.00%)", " Nausea 1/76 (1.32%)" ]

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

[ "Adverse Events 1:", " Total: 82/217 (37.79%)", " Febrile neutropenia 21/217 (9.68%)", " Neutropenia 4/217 (1.84%)", " Leukopenia 0/217 (0.00%)", " Anaemia 1/217 (0.46%)", " Thrombocytopenia 0/217 (0.00%)", " Atrial fibrillation 0/217 (0.00%)", " Arrhythmia 1/217 (0.46%)", " Arteriospasm coronary 0/217 (0.00%)", " Atrioventricular block first degree 0/217 (0.00%)", " Cardiac failure 0/217 (0.00%)", "Adverse Events 2:", " Total: 106/252 (42.06%)", " Febrile neutropenia 29/252 (11.51%)", " Neutropenia 13/252 (5.16%)", " Leukopenia 3/252 (1.19%)", " Anaemia 0/252 (0.00%)", " Thrombocytopenia 1/252 (0.40%)", " Atrial fibrillation 1/252 (0.40%)", " Arrhythmia 0/252 (0.00%)", " Arteriospasm coronary 1/252 (0.40%)", " Atrioventricular block first degree 1/252 (0.40%)", " Cardiac failure 1/252 (0.40%)" ]

[ "Adverse Events 1:", " Total: 6/40 (15.00%)", " Nausea 1/40 (2.50%)", " Vomiting 1/40 (2.50%)", " Chest pain 1/40 (2.50%)", " Hypercalcemia 1/40 (2.50%)", " Thromboembolism 2/40 (5.00%)" ]

[ "INTERVENTION 1: ", " All Study Participants, PA Compression Image Sets", " All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.", "INTERVENTION 2: ", " All Study Participants, TC Compression Image Sets", " All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers." ]

[ "INTERVENTION 1: ", " Overall Population", " Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population." ]

[ "Outcome Measurement: ", " Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4", " Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.", " Time frame: Baseline to Week 4", "Results 1: ", " Arm/Group Title: AZD0530 175 mg", " Arm/Group Description: AZD0530 (saracatinib) 175 mg once daily", " Overall Number of Participants Analyzed: 46", " Geometric Mean (95% Confidence Interval)", " Unit of Measure: Percentage change in betaCTX -71.1 (-75.9 to -65.4)", "Results 2: ", " Arm/Group Title: Zoledronic Acid 4 mg", " Arm/Group Description: Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period", " Overall Number of Participants Analyzed: 65", " Geometric Mean (95% Confidence Interval)", " Unit of Measure: Percentage change in betaCTX -68.4 (-73.0 to -63.2)" ]

[ "Inclusion Criteria:", " Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.", " Subjects with prior resection of brain metastases with progressions on brain MRI.", " Histologic confirmation of breast cancer.", " Age of study subject must be > 18 years.", " ECOG Performance Status 2.", " Ability to undergo brain MR and PET imaging", " Study subjects must have normal organ and marrow function as defined below:", " WBC >2,000/mmᶟ, platelets >90,000/mmᶟ, total bilirubin <2.0 mg/dl, creatinine <2.0 mg/dl.", " The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.", " Ability to understand, participate and provide a documented signed informed consent.", " Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.", "Exclusion Criteria:", " History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.", " Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.", " Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.", " Subjects who are unable to provide informed consent.", " Patients with prior whole brain radiotherapy.", " Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²" ]

[ "Inclusion Criteria:", " Patients", " with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)", " who received NAC", " with detectable lesion / clip marker on ultrasound", " with cT1-T3 tumors", " clinical and imaging complete or near-complete response on MRI", " with informed consent", "Exclusion Criteria:", " Multifocal cancer", " Residual microcalcification", " Contralateral breast cancer" ]

[ "Outcome Measurement: ", " Changes in QTcF After Treatment With DS-8201a in Participants With HER2-expressing Metastatic and/or Unresectable Breast Cancer", " The number of participants with notable electrocardiogram changes meeting predefined criteria is being reported.", " Time frame: Screening (within 7 days before enrollment) up to Cycle 3 Day 15 (each cycle is 21 days)", "Results 1: ", " Arm/Group Title: DS-8201a", " Arm/Group Description: Participants who received 6.4 mg/kg of DS-8201a as an intravenous (IV) infusion once every 3 weeks on Day 1 of each 21-day cycle.", " Overall Number of Participants Analyzed: 49", " Measure Type: Count of Participants", " Unit of Measure: Participants Maximum change from baseline in QTcF: >30 ms: 3 6.1%", " Maximum change from baseline in QTcF: >60 ms: 0 0.0%" ]

[ "Adverse Events 1:", " Total: 9/23 (39.13%)", " Anemia 1/23 (4.35%)", " Diarrhea 1/23 (4.35%)", " Nausea 1/23 (4.35%)", " Fracture 1/23 (4.35%)", " ALT 1/23 (4.35%)", " AST 1/23 (4.35%)", " INR 1/23 (4.35%)", " PTT 1/23 (4.35%)", " Glucose, high 1/23 (4.35%)", " Limb Pain 1/23 (4.35%)", " Ataxia 2/23 (8.70%)", " Neurology - Other 1/23 (4.35%)", " Seizure 1/23 (4.35%)", " Syncope 1/23 (4.35%)", " Confusion 1/23 (4.35%)" ]

[ "Adverse Events 1:", " Total: 14/52 (26.92%)", " Febrile neutropenia * 1/52 (1.92%)", " Tachycardia * 1/52 (1.92%)", " Atrial fibrillation * 0/52 (0.00%)", " Duodenal ulcer * 1/52 (1.92%)", " Gastric ulcer * 1/52 (1.92%)", " Nausea * 1/52 (1.92%)", " Abdominal pain * 0/52 (0.00%)", " Asthenia * 1/52 (1.92%)", " Disease progression * 1/52 (1.92%)", " Mucosal inflammation * 1/52 (1.92%)", " Appendicitis * 1/52 (1.92%)", "Adverse Events 2:", " Total: 4/20 (20.00%)", " Febrile neutropenia * 0/20 (0.00%)", " Tachycardia * 0/20 (0.00%)", " Atrial fibrillation * 1/20 (5.00%)", " Duodenal ulcer * 0/20 (0.00%)", " Gastric ulcer * 0/20 (0.00%)", " Nausea * 0/20 (0.00%)", " Abdominal pain * 1/20 (5.00%)", " Asthenia * 0/20 (0.00%)", " Disease progression * 0/20 (0.00%)", " Mucosal inflammation * 0/20 (0.00%)", " Appendicitis * 0/20 (0.00%)" ]

[ "Inclusion Criteria:", " Written informed consent", " Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.", " Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.", " Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.", " Patients without proven metastatic disease.", " Estrogen and progesterone receptors performed on the primary tumour prior to randomization.", " Age between 18 years and 70 years.", " Karnofsky performance status index > 80 %.", " Adequate hepatic, renal and heart functions.", " Adequate hematology levels.", " Negative pregnancy test", "Exclusion Criteria:", " Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).", " Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.", " Prior radiation therapy for breast cancer.", " Bilateral invasive breast cancer.", " Pregnant, or lactating patients.", " Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .", " Any T4 or N1-3 or M1 breast cancer.", " Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.", " Other serious illness or medical condition", " Past or current history of neoplasm other than breast carcinoma.", " Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.", " Lobular carcinoma in-situ (LCIS) of the breast.", " Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose", " Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.", " Definite contraindications for the use of corticosteroids.", " Concurrent treatment with other experimental drugs.", " Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.", " Concurrent treatment with any other anti-cancer therapy.", "Male patients." ]

[ "Inclusion Criteria:", " Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease", " Participant who in the Investigator's opinion requires combination therapy for their disease", " Life expectancy of greater than or equal to (>/=)12 weeks", "Exclusion Criteria:", " Previous chemotherapy for metastatic breast cancer", " Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)", " Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment" ]

[ "Adverse Events 1:", " Total: 55/238 (23.11%)", " Febrile neutropenia * 5/238 (2.10%)", " Neutropenia * 6/238 (2.52%)", " Leukopenia * 1/238 (0.42%)", " Thrombocytopenia * 0/238 (0.00%)", " Anaemia * 1/238 (0.42%)", " Pancytopenia * 0/238 (0.00%)", " Cardiac failure * 1/238 (0.42%)", " Acute coronary syndrome * 0/238 (0.00%)", " Atrial fibrillation * 0/238 (0.00%)", " Cardiac failure congestive * 0/238 (0.00%)", "Adverse Events 2:", " Total: 89/245 (36.33%)", " Febrile neutropenia * 12/245 (4.90%)", " Neutropenia * 10/245 (4.08%)", " Leukopenia * 2/245 (0.82%)", " Thrombocytopenia * 5/245 (2.04%)", " Anaemia * 1/245 (0.41%)", " Pancytopenia * 1/245 (0.41%)", " Cardiac failure * 2/245 (0.82%)", " Acute coronary syndrome * 1/245 (0.41%)", " Atrial fibrillation * 1/245 (0.41%)", " Cardiac failure congestive * 2/245 (0.82%)" ]

[ "INTERVENTION 1: ", " Flexitouch Device", " Lymphedema management via Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump)", "INTERVENTION 2: ", " Manual Lymphatic Drainage (MLD)", " Lymphedema management via self-administered manual lymphatic drainage therapy" ]

[ "Adverse Events 1:", " Total: 7/52 (13.46%)", " Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 0/52 (0.00%)", " Atrial Fibrillation * 1/52 (1.92%)", " Sepsis * 1/52 (1.92%)", " Muscle weakness upper limb * 1/52 (1.92%)", " Dizziness * 1/52 (1.92%)", " Seizure * 1/52 (1.92%)", " Nervous system disorders - Other, specify * [1]1/52 (1.92%)", "Adverse Events 2:", " Total: 1/30 (3.33%)", " Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1/30 (3.33%)", " Atrial Fibrillation * 0/30 (0.00%)", " Sepsis * 0/30 (0.00%)", " Muscle weakness upper limb * 0/30 (0.00%)", " Dizziness * 0/30 (0.00%)", " Seizure * 0/30 (0.00%)", " Nervous system disorders - Other, specify * [1]0/30 (0.00%)" ]

[ "Adverse Events 1:", " Total: 16/76 (21.05%)", " Hemoglobin 0/76 (0.00%)", " Left ventricular systolic function 1/76 (1.32%)", " Hypertension 0/76 (0.00%)", " Dehydration 1/76 (1.32%)", " Diarrhea 1/76 (1.32%)", " Hemorrhage, GI - stomach 0/76 (0.00%)", " Perforation, GI - colon 1/76 (1.32%)", " Ulcer, GI - stomach 0/76 (0.00%)", " Pain- head/headache 3/76 (3.95%)", " Pain- back 2/76 (2.63%)", "Adverse Events 2:", " Total: 5/29 (17.24%)", " Hemoglobin 1/29 (3.45%)", " Left ventricular systolic function 0/29 (0.00%)", " Hypertension 1/29 (3.45%)", " Dehydration 1/29 (3.45%)", " Diarrhea 0/29 (0.00%)", " Hemorrhage, GI - stomach 1/29 (3.45%)", " Perforation, GI - colon 0/29 (0.00%)", " Ulcer, GI - stomach 1/29 (3.45%)", " Pain- head/headache 0/29 (0.00%)", " Pain- back 0/29 (0.00%)" ]

[ "Inclusion Criteria:", " Tissue diagnosis of a breast carcinoma", " The oncologist must have prescribed doxorubicin as part of the planned chemotherapy regimen", " Have acceptable organ function within 14 days of enrollment defined as:", " liver function: total bilirubin, AST and ALT within normal institutional limits", " kidney function: estimated Creatinine Clearance > 60 ml/min calculated creatinine clearance (for females) - formula: (140 - age) x weight x .85 divided by (sCr x 72)", " At least 18 years old", " Patient must have given written informed consent indicating an understanding of the investigational nature of the study", " Agrees not to consume grapefruit juice while on the study", "Exclusion Criteria:", " Known allergy to enalapril", " Taking any known P450 cytochrome inducers or inhibitors", " Taking any herbal supplements while on the study or the week prior to receiving doxorubicin", " Taking an ace-inhibitor or angiotensin receptor blocker", " Pregnant or lactating. Enalapril is Pregnancy Categories C (first trimester) and D (second and third trimesters)" ]

[ "Adverse Events 1:", " Total: 39/39 (100.00%)", " Febrile Neutropenia 1/39 (2.56%)", " Heart failure 1/39 (2.56%)", " Diarrhea 3/39 (7.69%)", " Nausea/vomiting 4/39 (10.26%)", " Mucositis 3/39 (7.69%)", " Fatigue 4/39 (10.26%)", " infection 3/39 (7.69%)", " Urinary tract infection 2/39 (5.13%)", " Musculoskeletal pain 6/39 (15.38%)", " Syncope 1/39 (2.56%)", " Insomnia 3/39 (7.69%)", " Anxiety 2/39 (5.13%)" ]

[ "INTERVENTION 1: ", " Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2", " Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.", "INTERVENTION 2: ", " Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2", " Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days." ]

[ "INTERVENTION 1: ", " Supportive Care (Dakin's Solution, Radiation Therapy)", " Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.", " Dakin's solution: Applied topically", " radiation therapy: Undergo radiation therapy", " questionnaire administration: Ancillary studies", " laboratory biomarker analysis: Optional correlative studies" ]

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

[ "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%)" ]

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

[ "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." ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS)", " Progression free survival is defined as time from date of registration until the date of first documented disease progression or date of death from any cause, whichever occurs first.", " Time frame: From date of registration until disease progression or death, whichever occurs first", "Results 1: ", " Arm/Group Title: Avastin (Bevacizumab) Plus Hormone", " Arm/Group Description: All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.", " Overall Number of Participants Analyzed: 30", " Median (95% Confidence Interval)", " Unit of Measure: days 125.5 (90 to 256)" ]

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

[ "Inclusion Criteria:", " Histologically or cytologically confirmed breast cancer", " Metastatic disease", " Measurable disease, defined as >=1 unidimensionally measurable lesion, including >= 1 of the following:", " Lesion >= 10 mm on CT scan (5 mm sections)", " Lesion >= 20 mm on CT scan or MRI (10 mm sections)", " Bone disease that is >= 10 mm on MRI", " Lytic bone lesions that are >= 10 mm on CT scan (with 5 mm sections) OR >= 20 mm on plain film or CT scan (with 10 mm sections)", " Lesion >= 10 mm on physical exam", " Patients must have received >= 1 prior aromatase inhibitor in either the adjuvant or metastatic setting and must have had either disease recurrence or disease progression on a prior aromatase inhibitor therapy", " No brain metastases diagnosed within the past 6 months OR previously untreated brain metastases", " Estrogen receptor-positive and/or progesterone receptor-positive, defined as > 1% staining by immunohistochemistry or > 10 fmol/mg of protein by radio-ligand dextran-coated steroid binding assay", " Postmenopausal, as defined by 1 of the following:", " Prior bilateral oophorectomy", " No menses for >= 12 months in patients with an intact uterus", " Follicle-stimulating hormone (FSH) in postmenopausal range in patients < 60 years of age who have had a prior hysterectomy or have been amenorrheic for >= 3 months", " Age >= 60 years", " Pre- or perimenopausal patients receiving monthly injections of goserelin at a dose of 3.6 mg are eligible", " ECOG 0-2", " More than 3 months", " Absolute neutrophil count >= 1,500/mm3 Platelet count >= 100,000/mm3 No bleeding diathesis", " Bilirubin =< 1.5 times upper limit of normal (ULN AST and ALT =< 2.5 times ULN", " Systolic blood pressure (BP) < 150 mm Hg and diastolic BP < 100 mm Hg on at least one reading prior to study entry No uncontrolled hypertension", " None of the following within the past 6 months:", " Symptomatic congestive heart failure", " Unstable angina pectoris", " Myocardial infarction", " Cardiac arrhythmia with hemodynamic compromise", " Not pregnant or nursing", " Able to swallow oral medication", " No known HIV positivity", " No ongoing or active infection", " No psychiatric illness or social situation that would preclude study compliance", " No other active invasive malignancy within the past 5 years except nonmelanoma skin cancer or treated carcinoma in situ of the cervix", " No other uncontrolled illness", " More than 4 weeks since prior chemotherapy", " No more than 2 prior chemotherapy regimens for metastatic disease", " At least 8 weeks since prior anastrozole therapy", " Concurrent steroids allowed if dose is stable", " More than 4 weeks since prior radiotherapy", " More than 4 weeks since prior major surgery", " Recovered from prior therapy", " No prior sorafenib", " No concurrent therapeutic anticoagulation", " Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed provided PT and PTT are =< 1.5 times ULN", " No concurrent agents that may interact with sorafenib, including any of the following:", " Hypericum perforatum (St. John's wort)", " Rifampin", " P450 CYP3A4 enzyme-inducing anticonvulsants (e.g., phenytoin, carbamazepine, or phenobarbital)", " No other concurrent investigational agents", "Exclusion Criteria:", " estrogen receptor status unknown", " history of myocardial infarction within 6 months", " performance status 3", " performance status 4", " premenopausal", " progesterone receptor status unknown", "HIV positive" ]

[ "Adverse Events 1:", " Total: 19/70 (27.14%)", " Febrile Neutropenia 24/70 (5.71%)", " Pericarditis 21/70 (1.43%)", " Sinus bradycardia 21/70 (1.43%)", " Abdominal Pain 2/70 (2.86%)", " Diarrhea 21/70 (1.43%)", " Lower gastrointestinal hemorrhage 21/70 (1.43%)", " Nausea 21/70 (1.43%)", " Non Cardiac-Chest pain 22/70 (2.86%)", " Fever 24/70 (5.71%)", " Skin infection 41/70 (1.43%)", " Neutrophil count decreased 31/70 (1.43%)" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed adenocarcinoma of the breast, meeting one of the following criteria:", " Metastatic disease", " High-risk disease, defined as early-stage disease with pathologic involvement of locoregional lymph nodes", " Patients who are/will be receiving standard adjuvant trastuzumab [Herceptin®] for high-risk disease will participate in this study during the single-agent trastuzumab portion of their therapy", " No clinical or radiographical evidence of active disease", " Not eligible for therapy of known curative potential for metastatic breast cancer", " HER2/neu-overexpressing disease, defined as HER2/neu positive by IHC 3+ staining or by FISH+ amplification", " Stable CNS disease allowed provided it has been adequately treated and is not under active treatment", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " ECOG performance status 0-1", " ANC > 1,000/mm^3", " Platelet count > 100,000/mm^3", " Serum creatinine < 2.0 mg/dL", " Serum bilirubin 2.0 mg/dL (unless elevation is due to known Gilbert's syndrome)", " AST/ALT 2 times upper limit of normal (ULN)", " Alkaline phosphatase 5 times ULN", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " Cardiac ejection fraction normal by MUGA OR 45% by ECHO", " No other malignancies within the past 5 years, except for carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, or superficial bladder cancer", " No prior or currently active autoimmune disease* requiring management with systemic immunosuppression, including any of the following:", " Inflammatory bowel disease", " Systemic vasculitis", " Scleroderma", " Psoriasis", " Multiple sclerosis", " Hemolytic anemia or immune-mediated thrombocytopenia", " Rheumatoid arthritis", " Systemic lupus erythematosus", " Sjögren syndrome", " Sarcoidosis", " Other rheumatologic disease", " No symptomatic intrinsic lung disease or extensive tumor involvement of the lungs resulting in dyspnea at rest", " HIV-negative", " No evidence of active acute or chronic infection", " No uncontrolled medical problems", " No active major medical or psychosocial problems that could be complicated by study participation", " No corn allergy", " No known severe hypersensitivity to trastuzumab (except for mild to moderate infusion reactions that are easily managed and do not recur) NOTE: *Asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids allowed", " PRIOR CONCURRENT THERAPY:", " Any number of prior chemotherapy regimens for metastatic breast cancer allowed", " Prior or concurrent trastuzumab in the adjuvant or metastatic setting allowed", " More than 28 days since prior and no concurrent systemic oral steroids", " Topical, ocular, or nasal steroids allowed", " More than 28 days since prior and no concurrent chemotherapy, radiotherapy, or biologic therapy (except trastuzumab)", " More than 28 days since prior and no concurrent participation in another investigational clinical trial involving a new drug", " Concurrent endocrine therapy or bisphosphonates allowed" ]

[ "Inclusion Criteria:", " Written informed consent and ability to follow the Protocol procedures;", " Age from 18 years to 75 years inclusive;", " Female gender;", " Histologically confirmed breast cancer (BC);", " Metastatic BC (stage IV according to TNM classification version 6);", " Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH) ;", " Documented results of oestrogen and progesterone receptors expression analysis;", " Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization;", " Life expectancy - 20 weeks or more from the moment of randomization;", " Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial;", " Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug.", "Exclusion Criteria:", " Previous anticancer therapy for metastatic BC, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous hormonal therapy is allowed;", " Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy;", " Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization;", " Hypersensitivity to paclitaxel and all medications containing polyoxyethylated castor oil, hypersensitivity to dexamethasone, diphenhydramine, ranitidine/cimetidine, recombinant murine proteins, contrast agents or excipients of study medications;", " BC metastases in central nervous system, progressing or clinically manifested (e.g. cerebral oedema, spinal cord injury), with exception of non-progressing metastases not requiring treatment with glucocorticosteroids and/or anticonvulsants within 4 weeks prior to randomization;", " Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization;", " Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise);", " Left ventricular ejection fraction <50% according to electrocardiography;", " Neutrophils 1500/mm3;", " Platelets 100 000/mm3;", " Hemoglobin 90 g/L;", " Creatinine level 1.5 × upper limit of normal (ULN);", " Bilirubin level 1.5 × ULN;", " Asparagine transferase (AST) and alanine transferase (ALT) levels 2.5 × ULN (5 × ULN for patients with liver metastases);", " Alkaline phosphatase level 5 × ULN;", " Pregnancy or lactation;", " Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma;", " Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others);", " Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0;", " Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial;", " Acute or active chronic infections;", " Hepatitis C virus, hepatitis B virus, HIV or syphilis infections;", " Obstacles in intravenous administration of study drugs" ]

[ "Adverse Events 1:", " Total: 6/40 (15.00%)", " Nausea 1/40 (2.50%)", " Vomiting 1/40 (2.50%)", " Chest pain 1/40 (2.50%)", " Hypercalcemia 1/40 (2.50%)", " Thromboembolism 2/40 (5.00%)" ]

[ "INTERVENTION 1: ", " No Prophylaxis", " Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.", "INTERVENTION 2: ", " Naproxen 500 mg BID", " Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration." ]

[ "INTERVENTION 1: ", " Collective Placebo", " Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.", "INTERVENTION 2: ", " Pilocarpine 2 Times Per Day", " Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks." ]

[ "Adverse Events 1:", " Total: 67/240 (27.92%)", " Anaemia 0/240 (0.00%)", " Febrile neutropenia 1/240 (0.42%)", " Leukopenia 2/240 (0.83%)", " Neutropenia 1/240 (0.42%)", " Thrombocytopenia 0/240 (0.00%)", " Atrial fibrillation 0/240 (0.00%)", " Cardiac failure congestive 2/240 (0.83%)", " Cardiac tamponade 1/240 (0.42%)", " Cardio-respiratory arrest 1/240 (0.42%)", " Left ventricular dysfunction 0/240 (0.00%)", "Adverse Events 2:", " Total: 56/234 (23.93%)", " Anaemia 1/234 (0.43%)", " Febrile neutropenia 0/234 (0.00%)", " Leukopenia 0/234 (0.00%)", " Neutropenia 0/234 (0.00%)", " Thrombocytopenia 1/234 (0.43%)", " Atrial fibrillation 1/234 (0.43%)", " Cardiac failure congestive 0/234 (0.00%)", " Cardiac tamponade 0/234 (0.00%)", " Cardio-respiratory arrest 0/234 (0.00%)", " Left ventricular dysfunction 1/234 (0.43%)" ]

[ "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" ]

[ "INTERVENTION 1: ", " AB-101", " Apply to both nipple/areola regions approximately 1 hour prior to sexual activity", " AB-101: Apply approximately 1 hour prior to sexual activity", "INTERVENTION 2: ", " Placebo", " Apply to both nipple/areola regions approximately 1 hour prior to sexual activity", " Placebo: Apply approximately 1 hour prior to sexual activity" ]

[ "INTERVENTION 1: ", " Mammography Only", " For this reporting arm, the interpretation and analysis was done with mammography only.", "INTERVENTION 2: ", " Gamma Imaging", " For this reporting arm, the interpretation and analysis was done with gamma imaging only." ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed breast cancer", " Metastatic disease amenable to biopsy", " Unresected tumor with no intention to undergo resection during study", " Archival tissue from the primary diagnosis or fresh biopsy from metastatic cancer site required", " Measurable or non-measurable disease for phase I study (The Phase I portion of this study closed and the Phase II portion of the study opened as per NCCTG Addendum 6, effective January 23, 2012.)", " Measurable disease only for phase II study", " Available tumor estrogen (ER), progesterone (PR), and HER2 status from metastatic site tested by IHC or FISH OR results from the original tumor diagnosis", " Any ER, PR, or HER2 level (positive or negative) acceptable (phase I)", " Triple-negative disease only (phase II)", " ER and PR negative defined as 1% by IHC", " HER2 negative", " Patients with triple-negative breast cancer allowed provided there is clinical or radiographic evidence of tumor progression in the adjuvant or metastatic setting", " No patients whose disease can be treated with known standard therapy that is potentially curative or definitely capable of extending life expectancy", " No known CNS metastasis", " Hormone-receptor status:", " ER and PR positive or negative (phase I)", " ER and PR negative (phase II)", " PATIENT CHARACTERISTICS:", " ECOG performance status 0-1 (phase I) or 0-2 (phase II)", " Postmenopausal defined by 1 of the following:", " 60 years of age", " 45 years of age with last menstrual period 12 months prior and estradiol and follicle-stimulating hormone levels in postmenopausal range", " Bilateral oophorectomy", " Life expectancy 12 weeks", " ANC 1,500/mm^3", " Platelet count 100,000/mm^3", " Total bilirubin normal", " ALT and AST 3 times upper limit of normal (ULN) ( 5 times ULN if due to liver metastasis)", " Serum creatinine 1.5 times ULN", " TSH normal (thyroid hormone supplements allowed for patients with hypothyroidism)", " Not pregnant or nursing", " Fertile patients must use effective contraception", " Willing to return to Mayo Clinic or NCCTG institution (phase II) for follow-up", " Willing to provide blood samples for correlative research purposes", " No uncontrolled or intercurrent illness including, but not limited to, any of the following:", " Ongoing or active infection", " Symptomatic congestive heart failure", " Unstable angina pectoris", " Cardiac arrhythmia", " Psychiatric illness and/or social situations that would limit compliance with study requirements", " No NYHA class III or IV cardiovascular disease", " No known seizure disorder", " No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens", " No immunocompromised patients, including patients known to be HIV positive", " Immunocompromised patients due to the use of corticosteroids allowed", " No malignancy within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix", " No history of myocardial infarction 6 months", " No congenital long QT syndrome or QTcF>450 msec, including:", " Complete left bundle block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute)", " Right bundle branch block + left anterior hemiblock (bifascicular block)", " No congestive heart failure requiring use of maintenance therapy for life-threatening ventricular arrhythmias", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " More than 4 weeks since prior chemotherapy or radiotherapy and fully recovered", " No radiotherapy to > 25 % of bone marrow", " Prior treatments allowed (phase II):", " 0 or 1 prior chemotherapy regimens for breast cancer", " 2 prior aromatase-inhibitor regimens (including letrozole)", " Not currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered", " No other concurrent investigational agent for the primary neoplasm", " No concurrent CYP3A4 inhibitors or inducers" ]

[ "Outcome Measurement: ", " Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator", " PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.", " Time frame: From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months", "Results 1: ", " Arm/Group Title: Placebo + Letrozole 2.5 mg", " Arm/Group Description: Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib.", " Overall Number of Participants Analyzed: 108", " Measure Type: Count of Participants", " Unit of Measure: Participants 89 82.4%", "Results 2: ", " Arm/Group Title: Lapatinib 1500 mg + Letrozole 2.5 mg", " Arm/Group Description: Participants received 6 tablets of Lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib.", " Overall Number of Participants Analyzed: 111", " Measure Type: Count of Participants", " Unit of Measure: Participants 88 79.3%" ]

[ "Outcome Measurement: ", " Time to Disease Progression (Initial Treatment)", " Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.", " Time frame: Randomization date to the earliest date of first documented disease progression date or the date of death if the participant died due to study disease (up to 82 months)", "Results 1: ", " Arm/Group Title: Gemcitabine Plus Docetaxel", " Arm/Group Description: gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.", " Treatment continues until progression of disease at which time crossover treatment begins.", " Overall Number of Participants Analyzed: 239", " Median (95% Confidence Interval)", " Unit of Measure: months 9.28 (7.73 to 10.79)", "Results 2: ", " Arm/Group Title: Docetaxel Plus Capecitabine", " Arm/Group Description: docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.", " Overall Number of Participants Analyzed: 236", " Median (95% Confidence Interval)", " Unit of Measure: months 8.88 (7.37 to 11.05)" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR), Defined as the Proportion of Patients Who Have Had a Partial Response (PR) or Complete Response (CR) (RECIST 1.1 Based) Within the First 6 Months After Initiation of Therapy With Trametinib", " Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", " Time frame: 6 months", "Results 1: ", " Arm/Group Title: Treatment (Trametinib, Akt Inhibitor GSK2141795)", " Arm/Group Description: PART 1: Patients receive trametinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2.", " PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", " Akt Inhibitor GSK2141795: Given PO", " Laboratory Biomarker Analysis: Correlative studies", " Trametinib: Given PO", " Overall Number of Participants Analyzed: 37", " Measure Type: Count of Participants", " Unit of Measure: Participants 2 5.4%" ]

[ "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" ]

[ "Outcome Measurement: ", " Percentage of Progression Free Participants After 16 Weeks of Treatment", " Progression was defined according to 1 of the following criteria: New bone lesion(s) on bone scan or on magnetic resonance imaging; Progression or occurrence of new lesion(s) according to the Response Evaluation Criteria In Solid Tumours version 1.0 (RECIST); an increase in tumour marker CA 15.3 of more than 20 percent,compared with baseline, at 2 consecutive examinations; occurrence of disease-related skeletal events. If a patient did not fulfil any criteria and was withdrawn because of clinical deterioration amounting to PD according to the Investigator, they were considered as having PD.", " Time frame: 16 weeks", "Results 1: ", " Arm/Group Title: Afatinib 50 mg With Letrozole", " Arm/Group Description: Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.", " Overall Number of Participants Analyzed: 7", " Measure Type: Number", " Unit of Measure: Percentage of participants 28.57 (3.67 to 70.96)", "Results 2: ", " Arm/Group Title: Afatinib 40 mg With Letrozole", " Arm/Group Description: Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.", " Overall Number of Participants Analyzed: 13", " Measure Type: Number", " Unit of Measure: Percentage of participants 0.00 (0.00 to 24.71)" ]

[ "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: 7/7 (100.00%)", " Febrile neutropenia 3/7 (42.86%)", " Cardiac failure 1/7 (14.29%)", " Neutrophil count decreased 1/7 (14.29%)", " Muscular weakness 1/7 (14.29%)", " Epistaxis 1/7 (14.29%)", " Interstitial lung disease 1/7 (14.29%)", " Pleural effusion 2/7 (28.57%)" ]

[ "Adverse Events 1:", " Total: 8/101 (7.92%)", " Vertigo * 1/101 (0.99%)", " Infected lymphocele * 1/101 (0.99%)", " Ejection fraction decreased * 5/101 (4.95%)", " Lymphoedema * 1/101 (0.99%)" ]

[ "Inclusion Criteria:", " The patient must consent to participate in the study and must have signed an approved consent form conforming with federal and institutional guidelines.", " The patient must have a life expectancy of at least 10 years and a Zubrod performance status of 0 or 1. (Comorbid conditions but not the diagnosis of breast cancer should be taken into consideration when determining life expectancy.)", " The interval between the last surgery for breast cancer staging or treatment and randomization must be no more than 84 days.", " The tumor must be invasive carcinoma of the breast on histologic examination.", " All of the following staging criteria must be met:", " By clinical and pathologic evaluation, primary tumor must be T1-3;", " By clinical evaluation, ipsilateral nodes must be cN0, cN1, or cN2a;", " By pathologic evaluation, ipsilateral nodes must be pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b (only if due to microscopic involvement of internal mammary node detected by sentinel lymph node dissection and with more than 3 positive axillary lymph nodes).", " Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then progesterone receptor (PgR) analysis must be performed. If ER analysis is positive, PgR analysis is desired, but not mandatory. (\"Marginal\" or \"borderline\" results [i.e., those not definitely negative] will be considered positive regardless of the methodology used.)", " Patients must have had either a lumpectomy or a total mastectomy. Patients must have completed one of the following procedures for evaluation of pathologic nodal status.", " Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes (This approach is strongly recommended.)", " Sentinel lymphadenectomy alone if one of the following criteria is met:", " Pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1b", " Surgeon elects not to remove additional non-sentinel nodes (This approach is strongly discouraged, but will not preclude participation in B-38.)", " Axillary lymphadenectomy without sentinel node isolation procedure.", " Patients must have no clinical or radiologic evidence of metastatic disease.", " Patients with either skeletal pain or alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if bone scans fail to demonstrate metastatic disease. Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy.", " Patients with aspartate transaminase (AST) or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging fails to demonstrate metastatic disease and the following requirements are met at the time of randomization.", " Postoperative absolute granulocyte count (AGC) must be greater than or equal to 1200/mm3.", " Postoperative platelet count must be greater than or equal to 100,000/mm3.", " The following criteria for postoperative evidence of adequate hepatic function must be met:", " total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and", " alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and", " the AST must be less than or equal to 1.5 x ULN for the lab; and", " alkaline phosphatase and AST cannot both be greater than ULN.", " Postoperative serum creatinine must be less than or equal to ULN.", " At the time of randomization, the patient must have had the following: history and physical exam, EKG, and imaging of the chest within the past 3 months and bilateral mammogram within the past 6 months.", " Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF), measured by Multiple Gated Acquisition (MUGA) scan or echocardiogram, greater than or equal to lower limit of normal (LLN) for the facility performing the procedure and no evidence of regional wall abnormalities.", " Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.", " Special conditions for eligibility of lumpectomy patients: radiation therapy and surgery. Patients treated by lumpectomy must meet all the eligibility criteria in addition to the following:", " Generally, lumpectomy should be reserved for tumors less than 5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors greater than or equal to 5 cm are eligible if eligibility criteria for lumpectomy are met.", " The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients for whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary evaluation has been completed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.)", " Irradiation of regional lymph nodes is optional, but plans for radiation therapy must be declared by the investigator prior to randomization for stratification purposes.", " Special conditions for eligibility of mastectomy patients: radiation therapy o Postmastectomy chest wall and/or regional nodal irradiation is optional. Plans for radiation in mastectomy patients must be declared by the investigator prior to randomization for stratification purposes.", " Ineligibility Criteria", " Male patients are not eligible for this study. Women with one or more of the following conditions or prior therapies are also ineligible for this study:", " Tumor that has been determined to be human epidermal growth factor receptor 2 (HER2)-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).", " Contralateral breast cancer (invasive or DCIS) or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.", " Primary tumor staged as T4 for any reason.", " Clinical nodal stages including cN2b and cN3 or pathologic nodal stages including pN0(i+), pN2b, pN3b with clinically apparent internal mammary nodes, or pN3c.", " Suspicious nodes in the contralateral axilla or suspicious supraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor.", " Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible).", " Treatment, including radiation therapy, chemotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. One exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before randomization and be re-started, if indicated, following chemotherapy. A second exception is radiation therapy for patients enrolled in NSABP B-39 and assigned to partial breast irradiation (Group 2). These patients may have received RT prior to B-38 study entry.", " Prior therapy with anthracyclines or taxanes for any malignancy.", " Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.)", " Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen-receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Patients are eligible only if these medications are discontinued prior to randomization.", " Cardiac disease that would preclude the use of anthracyclines. This includes:", " history of myocardial infarction documented by elevated cardiac enzymes or regional wall abnormalities on assessment of left ventricular (LV) function;", " angina pectoris that requires the use of anti-anginal medication;", " any history of documented congestive heart failure;", " serious cardiac arrhythmia requiring medication;", " severe conduction abnormality;", " valvular disease with documented cardiac function compromise; and", " uncontrolled hypertension defined as blood pressure greater than 160/100 on antihypertensive therapy.", " Conditions that would prohibit administration of corticosteroids.", " Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI's Common Terminology Criteria for Adverse Events Version 3.0.", " Non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from receiving any of the treatment options or would prevent prolonged follow-up.", " History of hepatitis B or C.", " Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception.", " Concurrent treatment with other investigational agents for the treatment of breast cancer.", " Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.", " Special conditions for ineligibility of lumpectomy patients: radiation therapy and surgery", " For patients treated by lumpectomy, whole breast irradiation is required.", " The following patients will be ineligible:", " Patients with diffuse tumors (as demonstrated on mammography) treated with lumpectomy. (These patients are eligible if they undergo mastectomy.)", " Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.", " Patients in whom the margins of the resected specimen are involved with invasive tumor or DCIS." ]

[ "Inclusion Criteria:", " Postmenopausal women, Stage III or axillary node positive", " Currently disease free of breast cancer and other invasive malignancies at the time of registration", " No concurrent use of bisphosphonates", "Exclusion Criteria:", "Metastatic disease" ]

[ "Inclusion Criteria:", " Pathologically confirmed HER2-positive MBC", " Progression of or new brain metastases after completion of whole-brain radiotherapy or stereotactic radiosurgery", " Completion of whole-brain radiotherapy or stereotactic radiosurgery more than 60 days prior to enrollment", " Stable systemic disease", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1", " LVEF at least 50%", " Adequate hematologic, renal, and hepatic function", " Life expectancy more than 12 weeks", "Exclusion Criteria:", " Progression of systemic disease at Screening", " Leptomeningeal disease", " History of intolerance or hypersensitivity to study drug", " Use of certain investigational therapies within 21 days prior to enrollment", " Current anthracycline use", " Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use", " Active infection", " Pregnant or lactating women", " Significant history or risk of cardiac disease", " Symptomatic intrinsic lung disease or lung involvement", " History of other malignancy within the last 5 years" ]

[ "Outcome Measurement: ", " 1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)", " PFS was defined as the time from randomization to progressive disease, or death, whichever occurs first. Response was assessed according to RECIST 1.1 by BICR. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression. All participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue.", " Time frame: From Day 1 through last post-study efficacy follow-up (up to ~19 months)", "Results 1: ", " Arm/Group Title: Ridaforolimus + Dalotuzumab + Exemestane", " Arm/Group Description: Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 40", " Median (95% Confidence Interval)", " Unit of Measure: Weeks 23.29 (8.71 to 38.43)", "Results 2: ", " Arm/Group Title: Ridaforolimus + Exemestane", " Arm/Group Description: Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 40", " Median (95% Confidence Interval)", " Unit of Measure: Weeks 31.86 (16.00 to 39.29)" ]

[ "INTERVENTION 1: ", " Prone", "Prone position", "INTERVENTION 2: ", " Supine", "Supine position" ]

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

[ "Outcome Measurement: ", " Central Nervous System (CNS) Objective Response Rate", " CNS objective response rate is the percentage of participants that achieve CNS complete or partial response as follows:", " CNS complete response (CR) is achieved if all of the following are satisfied:", " Complete resolution of all measurable (>= 1 cm in longest dimension [LD]) and non-measurable brain metastases", " No new CNS lesions (defined as any new lesion >= 6 mm in LD)", " Stable or decreasing steroid dose", " No new/progressive tumor-related neurologic signs or symptoms", " No progression of extra-CNS disease as assessed by RECIST", " CNS partial response (PR) is achieved if all of the following are satisfied:", " ->/= 50% reduction in the volumetric sum of all measurable (>/= 1 cm in LD) brain metastases compared to baseline", " No progression on non-measurable lesions", " No new CNS lesions (defined as any new lesion >/= 6 mm in LD)", " Stable or decreasing steroid dose", " No new/progressive tumor-related neurologic signs or symptoms", " No progression of extra-CNS disease as assessed by RECIST", " Time frame: Response was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment duration for this study cohort was a median (range) of 8 cycles (1-20) which approximates months given the 4 week cycle length.", "Results 1: ", " Arm/Group Title: Carboplatin, Bevacizumab, Trastuzumab (if HER2+)", " Arm/Group Description: Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration is 28 days.", " carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle", " bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle", " trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only", " *8mg/kg loading dose in cycle 1 for some participants", " HER-2: human epidermal growth factor receptor 2", " Overall Number of Participants Analyzed: 38", " Measure Type: Number", " Unit of Measure: percentage of participants 63 (47 to 77)" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: 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) = CR + PR.", " Time frame: Up to 2 years.", "Results 1: ", " Arm/Group Title: NKTR-102 14 Day", " Arm/Group Description: NKTR-102: NKTR-102 given on a q14 day schedule", " Overall Number of Participants Analyzed: 35", " Measure Type: Number", " Unit of Measure: percentage of subjects 28.6 (14.6 to 46.3)", "Results 2: ", " Arm/Group Title: NKTR-102 21 Days", " Arm/Group Description: NKTR-102: NKTR-102 given on a q21 day schedule", " Overall Number of Participants Analyzed: 35", " Measure Type: Number", " Unit of Measure: percentage of subjects 35 (14.6 to 46.3)" ]