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nli4ct_semeval2024

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[ "Adverse Events 1:", " Total: 7/45 (15.56%)", " Febrile neutropenia 1/45 (2.22%)", " Cardiac ischemia/infarction 1/45 (2.22%)", " Ventricular arrhythmia - left ventricular systolic dysfunction 1/45 (2.22%)", " Hemmorhage - GI 1/45 (2.22%)", " Pancreatitis 1/45 (2.22%)", " Infection - pneumonia 1/45 (2.22%)", " Infection - Streptococcus 1/45 (2.22%)", " Abcess of Bartholin's cyst 1/45 (2.22%)" ]

[ "Inclusion:", " Histologically confirmed breast cancer", " Clinically or radiographically measurable residual tumor after core biopsy", " Eastern Cooperative Oncology Group (ECOG) performance status 0-1", " Age 18 yrs", " Absolute neutrophil count 1,500/mm³", " Hemoglobin 9 g/dL", " Platelet count 100,000/ mm³", " Creatinine 1.5 times upper limit of normal (ULN)", " Urine protein:creatinine ratio < 1.0", " AST (aspartate aminotransferase) and ALT 2.5 times ULN", " Alkaline phosphatase 2.5 times ULN", " Bilirubin normal", " Women of childbearing potential must use effective contraception", " Left ventricular ejection fraction (LVEF) normal by echocardiogram or MUGA", " Exclusion:", " No residual tumor after initial biopsy", " Peripheral neuropathy of grade 2 or higher", " HER-2 neu overexpression either by IHC 3+ or FISH+", " No history of any prior treatment of breast cancer.", " No history of unstable angina or myocardial infarction within the past 12 months", " Pregnant or nursing women", " Anticoagulation therapy within the last 6 months", " History of gastrointestinal bleeding", " Recent hemoptysis", " No known hepatitis B or HIV seropositivity", " No inadequately controlled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg despite antihypertensive medications", " History of hypertensive crisis or hypertensive encephalopathy", " New York Heart Association class II-IV congestive heart failure", " History of stroke or transient ischemic attack at any time", " Significant vascular disease (e.g., aortic aneurysm or aortic dissection)", " No symptomatic peripheral vascular disease", " Evidence of bleeding diathesis or coagulopathy", " Significant traumatic injury within the past 28 days", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months", " Serious, non-healing wound, ulcer, or bone fracture", " Known hypersensitivity to any component of bevacizumab" ]

[ "Inclusion Criteria:", " Woman, 18 years old or upper.", " Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:", " immuno-histochemistry (IHC) 3+ (>10% of tumor cells with complete and intense membrane staining)", " IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (*)", " FISH / CISH / SISH + for HER 2 amplification (*) (*) Defined as the ratio of copies of HER 2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER 2/neu> 6, as per local laboratory criteria.", " Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.", " No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months.", " Adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2.", " Adequate bone marrow function, liver and kidney", " Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).", " The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.", " The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.", "Exclusion Criteria:", " Patients with no advanced breast cancer.", " Breast cancer patients with tumors HER 2-negative.", " The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included.", " The patient has uncontrolled brain metastases.", " Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.", " Known hypersensitivity to trastuzumab or to any of its components.", " Patients with severe dyspnea at rest or requiring supplemental oxygen.", " Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled.", " Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).", " The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment." ]

[ "Inclusion Criteria:", " Age 18 and 85 years", " Postmenopausal status defined as: no menstrual cycle in the past 12 months hysterectomy with bilateral oophorectomy hysterectomy with intact ovaries if age > 55 years", " Newly diagnosed with incident, primary, invasive, estrogen receptor positive clinical stage II or lower breast cancer", " ECOG performance status of 1 or less", " Willingness to comply with study guidelines and procedures", " Willingness and ability to provide informed consent", " Usual consumption of soy no more than 1 time per week and willingness to avoid whole soy foods or concentrated soy sources (soy milk, tofu, substitute meat products, meal replacement bars) during the intervention period", " Willingness to avoid herbal and dietary supplements (not including vitamins), aspirin, and ibuprofen during the intervention period", " No competing neoadjuvant or chemotherapy treatment", " Time between pre-surgical visit and surgery must be at least 2 weeks", " No chemotherapy in the past 12 months", "Exclusion Criteria:", " Inability to read and write English", " Previous invasive breast cancer", " Insulin dependent Type I or II diabetes diagnosed by physician", " History of coagulopathy, thrombocytopenia, or bleeding disorder", " Current (past 30 days) regular (at least once per week) use of reproductive hormone therapy, Tamoxifen, aromatase inhibitors, or other estrogen inhibitors, flaxseed, or antibiotics", " Current chemotherapy or neoadjuvant chemotherapy", " Allergies to flaxseed, nuts, or other seeds", " Renal dysfunction defined as creatinine > 1.5 mg/dl", " History of Crohns' disease, ulcerative colitis, irritable bowel syndrome, celiac sprue, or other malabsorption syndrome, diverticulitis, diverticulosis, or other bowel diagnosis which, in the opinion of the breast surgeon, would contraindicate large doses of dietary fiber or would impair nutrient absorption", " Current, regular (more than once weekly) use of prescription blood-thinning agents including coumadin, heparin and heparin related drugs, clopidogrel bisulfate" ]

[ "Outcome Measurement: ", " Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population", " Safety was assessed from first dose of study drug through at least 30 days after the last dose, until resolution of drug-related toxicity or when toxicity was deemed irreversible, whichever was longer. An adverse event (AE) was considered a dose limiting toxicity (DLT) if it occurred in the first 21 days and was at least possibly related to study drugs and were: Clinically-evident toxicity of Grade >= 3, or of Grade 2 which required interruption of treatment for >= 7 days (consecutive or non-consecutive); non-hematologic abnormal laboratory value of Grade >= 3, or hematologic toxicity of Grade 4, which persisted 7 days; any grade toxicity which in the judgment of the investigator required a dose reduction or removal from further study therapy.", " Time frame: Day 1 to 30 days post last dose", "Results 1: ", " Arm/Group Title: 50 mg Dasatinib + 825 mg/m^2Capecitabine", " Arm/Group Description: Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.", " Overall Number of Participants Analyzed: 7", " Measure Type: Number", " Unit of Measure: participants 1", "Results 2: ", " Arm/Group Title: 70 mg Dasatinib + 825 mg/m^2Capecitabine", " Arm/Group Description: Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.", " Overall Number of Participants Analyzed: 9", " Measure Type: Number", " Unit of Measure: participants 1" ]

[ "Adverse Events 1:", " Total: 27/94 (28.72%)", " Anaemia 2/94 (2.13%)", " Febrile neutropenia 2/94 (2.13%)", " Leukopenia 1/94 (1.06%)", " Neutropenia 0/94 (0.00%)", " Thrombocytopenia 1/94 (1.06%)", " Arrhythmia 0/94 (0.00%)", " Atrial fibrillation 0/94 (0.00%)", " Cardiac failure congestive 0/94 (0.00%)", " Cardiomyopathy 0/94 (0.00%)", " Pericardial effusion 0/94 (0.00%)", " Tachycardia 0/94 (0.00%)", "Adverse Events 2:", " Total: 36/93 (38.71%)", " Anaemia 2/93 (2.15%)", " Febrile neutropenia 9/93 (9.68%)", " Leukopenia 3/93 (3.23%)", " Neutropenia 4/93 (4.30%)", " Thrombocytopenia 1/93 (1.08%)", " Arrhythmia 1/93 (1.08%)", " Atrial fibrillation 1/93 (1.08%)", " Cardiac failure congestive 3/93 (3.23%)", " Cardiomyopathy 2/93 (2.15%)", " Pericardial effusion 1/93 (1.08%)", " Tachycardia 1/93 (1.08%)" ]

[ "Adverse Events 1:", " Total: 0/77 (0.00%)", " Neutropenia [1]0/77 (0.00%)", " Left ventricular dysfunction 0/77 (0.00%)", " Cardiac ischemia 0/77 (0.00%)", " Gastrointestinal pain 0/77 (0.00%)", " Colitis 0/77 (0.00%)", " Febrile neutropenia 0/77 (0.00%)", " Pulmonary/upper respiratory infection 0/77 (0.00%)", " Diverticulitis 0/77 (0.00%)", " Motor neuropathy 0/77 (0.00%)", " Endometrial mucosa thinkening 0/77 (0.00%)", "Adverse Events 2:", " Total: 12/85 (14.12%)", " Neutropenia [1]1/85 (1.18%)", " Left ventricular dysfunction 1/85 (1.18%)", " Cardiac ischemia 2/85 (2.35%)", " Gastrointestinal pain 1/85 (1.18%)", " Colitis 1/85 (1.18%)", " Febrile neutropenia 3/85 (3.53%)", " Pulmonary/upper respiratory infection 1/85 (1.18%)", " Diverticulitis 1/85 (1.18%)", " Motor neuropathy 1/85 (1.18%)", " Endometrial mucosa thinkening 1/85 (1.18%)" ]

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

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

[ "Adverse Events 1:", " Total: 5/11 (45.45%)", " Diabetes insipidus [1]1/11 (9.09%)", " Nausea 0/11 (0.00%)", " Ileus 1/11 (9.09%)", " Dehydration 1/11 (9.09%)", " Vomiting 0/11 (0.00%)", " Pain NOS [2]2/11 (18.18%)", " Pain - abdomen 0/11 (0.00%)", " Fracture [3]0/11 (0.00%)", " Progressive Disease 1/11 (9.09%)", " CNS Ischemia 1/11 (9.09%)", " Respiratory Failure 0/11 (0.00%)", " Hypoxia 1/11 (9.09%)", "Adverse Events 2:", " Total: 8/21 (38.10%)", " Diabetes insipidus [1]0/21 (0.00%)", " Nausea 1/21 (4.76%)", " Ileus 0/21 (0.00%)", " Dehydration 1/21 (4.76%)", " Vomiting 1/21 (4.76%)", " Pain NOS [2]0/21 (0.00%)", " Pain - abdomen 1/21 (4.76%)", " Fracture [3]1/21 (4.76%)", " Progressive Disease 1/21 (4.76%)", " CNS Ischemia 1/21 (4.76%)", " Respiratory Failure 1/21 (4.76%)", " Hypoxia 1/21 (4.76%)" ]

[ "INTERVENTION 1: ", " Treatment Schedule (Weekly)", " Arm C, Docetaxel and Gemcitabine (Weekly):", " Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Arm D, Paclitaxel and Gemcitabine (Weekly):", " Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", "INTERVENTION 2: ", " Treatment Schedule (3 Weekly)", " Arm A, Docetaxel and Gemcitabine (3 Weekly):", " Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Arm B, Paclitaxel and Gemcitabine (3 Weekly):", " Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.", " Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD." ]

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

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

[ "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" ]

[ "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" ]

[ "INTERVENTION 1: ", " IUS Alone", "IUS alone imaging", "INTERVENTION 2: ", " Imagio (IUS+OA)", "IUS+OA imaging" ]

[ "INTERVENTION 1: ", " All Study Participants: Patient Assisted Compression", " All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.", " Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.", "INTERVENTION 2: ", " All Study Participants: Technologist Compression", " All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.", " Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site." ]

[ "INTERVENTION 1: ", " Akt Inhibitor MK-2206", " Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days." ]

[ "Inclusion Criteria:", " The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines", " The patient must be 18 years or older.", " Core biopsy should definitively demonstrate invasive carcinoma.", " Invasive carcinoma should be ER-apha receptor positive", " The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible.", " Patients in whom surgical excision of the tumor is part of standard of care management", " ECOG score of 0 or 1", " Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)", " Consent to participate in DBBR (RPCI only)", "Exclusion Criteria:", " Male patients are not eligible for this study", " Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.", " Patients with diagnosis by FNA cytology only", " Pregnant or lactating women", " Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy", " Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible", " Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision", " Psychiatric or addictive disorders that would preclude obtaining informed consent", " Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism", " Women with non-invasive disease or microinvasion are not eligible.", " Women undergoing neoadjuvant chemotherapy are not eligible", " women currently on tamoxifen and raloxifene for prevention are not eligible", " Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh.", " Patients with a known mutation in p53 (Li Fraumeni Syndrome)" ]

[ "Adverse Events 1:", " Total: 51/486 (10.49%)", " ANEMIA 1/486 (0.21%)", " NEUTROPENIA 4/486 (0.82%)", " FIBRILLATION ATRIAL 1/486 (0.21%)", " ABDOMINAL PAIN 2/486 (0.41%)", " BLOATING 1/486 (0.21%)", " BOWEL PERFORATION 1/486 (0.21%)", " COLITIS 1/486 (0.21%)", " DEHYDRATION 5/486 (1.03%)", " DIARRHEA 5/486 (1.03%)", " GASTRIC INFLAMMATION 1/486 (0.21%)", " NAUSEA 3/486 (0.62%)", " NAUSEA AND VOMITING 1/486 (0.21%)", "Adverse Events 2:", " " ]

[ "Adverse Events 1:", " Total: 17/40 (42.50%)", " Anaemia 2/40 (5.00%)", " Febrile Neutropenia 3/40 (7.50%)", " Neutropenia 2/40 (5.00%)", " Thrombocytopenia 5/40 (12.50%)", " Pericardial Effusion 1/40 (2.50%)", " Abdominal Pain Lower 1/40 (2.50%)", " Disease Progression 6/40 (15.00%)", " Fatigue 1/40 (2.50%)", " Pyrexia 3/40 (7.50%)", " Septic Shock 1/40 (2.50%)", " Streptococcal Infection 1/40 (2.50%)" ]

[ "Inclusion Criteria:", " Patient is an adult, 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines", " Women and men with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.", " Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive and HER2-negative breast cancer by local laboratory. Local pathology is sufficient for assessment.", " Patient must have either:", " Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria ).", " Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease", " Non-measurable disease", " Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 2", " Exclusion Criteria", " Patient who received any CDK4/6 inhibitor or any mTOR inhibitor.", " Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole", " Patients with current inflammatory breast cancer.", " Patient has received > 1 chemotherapy for the treatment of advanced/metastatic breast cancer", " Patient has received > 2 endocrine therapies for the treatment of advanced/metastatic breast cancer", " Patient has central nervous system (CNS) involvement. If patient is fulfilling the following 3 criteria she/he is eligible for the trial.", " completed prior therapy (including radiation and/or surgery) for CNS metastases 28 days prior to the start of study and", " CNS tumor is clinically stable at the time of screening and", " Patient is not receiving steroids and enzyme inducing anti-epileptic medications for brain metastases", " Patient has active cardiac disease or a history of cardiac dysfunction" ]

[ "Inclusion Criteria:", " Stage 1-2 invasive breast cancer diagnosis,", " DCIS", " Ability to read English", "Exclusion Criteria:", "Male" ]

[ "Inclusion Criteria:", " A subject will be eligible for study participation if all of the following criteria are met at Screening:", " Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved by an Independent Ethics committee (IEC) prior to any study related activities", " Females 18 years", " Histologically confirmed and documented invasive breast cancer", " Breast cancer without evidence of distant metastases (Stage 4) based on staging work-up", " Chemotherapy naive, who have not received chemotherapy in the neoadjuvant setting and who are candidates for chemotherapy in the adjuvant setting of taxane/cyclophosphamide-based regimen, e.g., TAC, as background chemotherapy", " Zubrod/WHO/ECOG performance status 2", " Adequate bone marrow, hepatic, and renal function reserve as evidenced by:", " Hemoglobin 10 mg/dl", " ANC 1.5 x 10^9/L", " Platelet count of 100 x 10^9/L", " Total bilirubin 2 mg/dl", " Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) 3 x the upper limit of normal (ULN) of the reference lab", " Serum creatinine of 1.5 x ULN for reference lab or estimated glomerular filtration rate (eGFR) of 60 mg/min", " Body mass index (BMI) of 19 to 40 kg/m^2 , inclusive", " Subjects of childbearing potential, and their partners, agree to pregnancy prevention throughout the duration of the study (through the Follow-up Visit). Specific type of pregnancy prevention should be discussed with, and acceptable to, the treating oncologist in the context of the tumoral hormone receptor status. Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study", " Medically acceptable forms of birth control can include, with approval of the treating physician:", " Barrier methods (condom or diaphragm with spermicide)", " Intrauterine device (IUD)", " Hormone contraceptives (such as oral [pill], injection, skin patch, implant, cervical ring)", " Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. Sexually active subjects must use contraception while on HSP-130 from admission to the final Follow-up Visit", " Able to understand verbal or written instructions and comply with all study requirements, to communicate effectively with study personnel and is available for the planned duration of the study", "Exclusion Criteria:", " A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:", " Previous G-CSF exposure, including filgrastim, lenograstim, pegfilgrastim, lipegfilgrastim, granulocyte/macrophage colony stimulating growth factor (GM-CSF), or any other branded or biosimilar G-CSF", " Prior autologous stem cell harvest of any type", " Drug sensitivity, allergic reaction, or known hypersensitivity or idiosyncratic reaction to E. coli - derived proteins, filgrastim, other G-CSFs, or pegylated agents", " Known hypersensitivity to docetaxel, polysorbate 80, or doxorubicin", " For subjects receiving doxorubicin, no concurrent use of inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp or with trastuzumab due to increased risk of cardiac dysfunction", " Chemotherapy other than that included in this study (taxane/cyclophosphamide-based regimen, e.g., TAC or TC) or neoadjuvant chemotherapy; or known immunosuppressive agents including chronic oral corticosteroid use, or radiation therapy within 4 weeks of first dose of HSP-130, prior bone marrow or stem cell transplantation, or malignancy within 5 years", " Known HER2 + ( overexpressing breast cancer)", " Known triple negative (estrogen receptor-negative, progesterone receptor-negative and HER2-negative) breast cancer", " Grade 2 underlying neuropathy", " Current diagnosis of active tuberculosis or other severe infection, such as sepsis, abscesses or opportunistic infections", " Treatment with systemically active antibiotics within 72 hours before chemotherapy", " Known infection with HIV", " Known sickle cell disease", " Known severe persistent drug-induced myelosuppression", " New York Heart Association (NYHA) class III or IV heart failure, severe uncontrolled cardiac disease (unstable angina, clinically significant ECG abnormalities) or MI within the previous 6 months before the first administration of HSP-130", " Any malignancy other than breast cancer, with exception of adequately treated squamous or basal cell carcinoma of the skin or cervical carcinoma in situ, within 5 years before the first administration of the HSP-130", " Current or recent treatment (within 30 days before the first administration of the HSP-130) with any other investigational medicinal product", " Pregnancy or lactation; Subjects planning to be pregnant or to breastfeed before, during, or within 12 months after administration of the HSP-130 are not permitted to enroll in the study", " Received a live, live-attenuated, or non-live vaccine within 4 weeks before the first administration of the HSP-130", " Patient has evidence of any other coexisting disease or medical or psychological condition, metabolic dysfunction, physical examination finding or clinical lab finding giving reasonable suspicion of a disease or condition that contraindicated the use of an HSP-130, or patient is high risk for treatment complication" ]

[ "Inclusion Criteria:", " Patients must have histologically-confirmed adenocarcinoma of the breast with operable or inoperable stage 1c (primary tumor > 1.0 cm), II or III disease.", " Measurable disease by physical examinations or diagnostic breast imaging (mammography, ultrasonography or MR).", " Pre-treatment core or incisional biopsy. Patients may not have had definitive primary surgery.", " Male or female, 18 years of age or older.", " ECOG performance status 0 or 1.", " Adequate organ function as defined in the protocol.", "Exclusion Criteria:", " Prior radiation therapy, cytotoxic therapy or systemic therapy for breast cancer. Prior use of tamoxifen or raloxifene as chemoprevention is allowed but must be discontinued prior to study entry.", " Metastatic (Stage IV) breast cancer", " Patients who have had only a pre-treatment fine needle aspiration (FNA) are excluded.", " Current therapeutic treatment on another clinical trial with an investigational agent.", " Any of the following within the 6 months prior to starting study treatment: -myocardial infarction -severe/unstable angina -coronary/peripheral artery bypass graft -congestive heart failure -cerebrovascular accident including transient ischemic attack -pulmonary embolus", " Ongoing cardiac dysrhythmias of NCI CTCAE grade >=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.", " Hypertension that cannot be controlled by medications.", " Current treatment with therapeutic doses of any anti-coagulant. Prophylactic use of anticoagulants is allowed.", " Known human immunodeficiency virus (HIV) infection.", " Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test prior to first day of study medication.", " Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study." ]

[ "Adverse Events 1:", " Total: 14/69 (20.29%)", " Febrile neutropenia 0/69 (0.00%)", " Anaemia 0/69 (0.00%)", " Atrial fibrillation 1/69 (1.45%)", " Cardiopulmonary failure 0/69 (0.00%)", " Supraventricular extrasystoles 1/69 (1.45%)", " Abdominal pain 1/69 (1.45%)", " Intestinal obstruction 0/69 (0.00%)", " Vomiting 1/69 (1.45%)", " Chills 1/69 (1.45%)", " Oedema peripheral 0/69 (0.00%)", " Pyrexia 1/69 (1.45%)", "Adverse Events 2:", " Total: 17/66 (25.76%)", " Febrile neutropenia 6/66 (9.09%)", " Anaemia 1/66 (1.52%)", " Atrial fibrillation 1/66 (1.52%)", " Cardiopulmonary failure 1/66 (1.52%)", " Supraventricular extrasystoles 0/66 (0.00%)", " Abdominal pain 0/66 (0.00%)", " Intestinal obstruction 1/66 (1.52%)", " Vomiting 0/66 (0.00%)", " Chills 0/66 (0.00%)", " Oedema peripheral 1/66 (1.52%)", " Pyrexia 0/66 (0.00%)" ]

[ "Adverse Events 1:", " Total: 0/244 (0.00%)", " Pregnancy *0/244 (0.00%)", " Endocervical cancer *0/244 (0.00%)", " Nosocomial pneumonia *0/244 (0.00%)", " Venous thrombosis *0/244 (0.00%)", "Adverse Events 2:", " Total: 5/255 (1.96%)", " Pregnancy *1/255 (0.39%)", " Endocervical cancer *1/255 (0.39%)", " Nosocomial pneumonia *2/255 (0.78%)", " Venous thrombosis *1/255 (0.39%)" ]

[ "Adverse Events 1:", " Total: 26/69 (37.68%)", " Thrombophlebitis * 1/69 (1.45%)", " Anaemia NOS * 1/69 (1.45%)", " Acute febrile neutrophilic dermatosis * 1/69 (1.45%)", " Cardiac failure NOS * 2/69 (2.90%)", " Ejection fraction decreased * 1/69 (1.45%)", " Intestinal obstruction NOS * 1/69 (1.45%)", " Diarrhoea NOS * 2/69 (2.90%)", " Febrile neutropenia * 12/69 (17.39%)", " Mucosal inflammation NOS * 1/69 (1.45%)" ]

[ "Outcome Measurement: ", " Overall Survival", " The main endpoint of this study is overall survival defined as the time from randomisation to the date of death or last follow-up. For patients who have not died, survival duration will be censored at the date of last contact or last follow-up or the date of last news.", " Time frame: From baseline up to 3 years 1 month", "Results 1: ", " Arm/Group Title: Vinflunine", " Arm/Group Description: Patients randomised in the test arm (arm A) received VFL at the dose of 280 mg/m on day 1 of each cycle every 3 weeks, over a 20-minute intravenous (IV) infusion. Cycles were repeated every 3 weeks.", " vinflunine: 280 mg/m2 on day 1 of each cycle every 3 weeks", " Overall Number of Participants Analyzed: 298", " Median (95% Confidence Interval)", " Unit of Measure: Months 9.1 (7.7 to 10.4)", "Results 2: ", " Arm/Group Title: Alkylating Agent", " Arm/Group Description: Patients randomised in the control arm (arm B) received an alkylating agent used as a single agent which was available in the investigational center and was approved for the treatment of cancer in the country.", " Alkylating agent of physician choice registered in cancer: cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin", " Overall Number of Participants Analyzed: 296", " Median (95% Confidence Interval)", " Unit of Measure: Months 9.3 (7.5 to 10.9)" ]

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

[ "INTERVENTION 1: ", " Monotherapy: Alobresib 0.6 mg", " Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 0.6 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD.", "INTERVENTION 2: ", " Monotherapy: Alobresib 1.4 mg", " Participants with advanced solid tumors and lymphomas who had failed or were intolerant to standard therapy, or for whom no standard therapy existed received alobresib tablets at a dose of 1.4 mg orally once daily on Study Day 1 through C1D28 of 28 days cycle to determine the MTD." ]

[ "Inclusion Criteria:", " unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)", " stage II or III unilateral secondary upper extremity lymphedema (as defined by the International Society of Lymphology)", " girth 2 cm circumferential difference and/or volume 200 mL compared to the uninvolved upper extremity at any 4 cm segment", " able to commit to a long term follow-up schedule", "Exclusion Criteria:", " active cancer/metastatic cancer", " currently receiving or have plans for adjuvant radiation or chemotherapy", " pregnant", " presence of other extremity lymphedema (primary or secondary)", " pacemaker", " artificial joints in the upper quadrants", " renal failure", " arterial insufficiency", " congestive heart failure", " chronic inflammatory conditions", " history of deep vein thrombosis (DVT) in the lymphedematous upper extremity", " previous treatment with Low Level Laser (regardless of indication)", " medication(s) known to affect body fluid balance", " body mass index (BMI) > 40 (morbid obesity)" ]

[ "Adverse Events 1:", " Total: 10/50 (20.00%)", " Anaemia 0/50 (0.00%)", " Febrile neutropenia 0/50 (0.00%)", " Neutropenia 0/50 (0.00%)", " Thrombocytopenia 0/50 (0.00%)", " Diastolic dysfunction 0/50 (0.00%)", " Tachycardia 0/50 (0.00%)", " Intestinal obstruction 0/50 (0.00%)", " Nausea 1/50 (2.00%)", " Oesophageal spasm 0/50 (0.00%)", " Oesophagitis 0/50 (0.00%)", " Retching 0/50 (0.00%)", "Adverse Events 2:", " Total: 11/48 (22.92%)", " Anaemia 4/48 (8.33%)", " Febrile neutropenia 0/48 (0.00%)", " Neutropenia 2/48 (4.17%)", " Thrombocytopenia 2/48 (4.17%)", " Diastolic dysfunction 1/48 (2.08%)", " Tachycardia 1/48 (2.08%)", " Intestinal obstruction 0/48 (0.00%)", " Nausea 0/48 (0.00%)", " Oesophageal spasm 1/48 (2.08%)", " Oesophagitis 0/48 (0.00%)", " Retching 1/48 (2.08%)" ]

[ "Inclusion Criteria:", " women >=18 years of age;", " >=1 target lesion;", " locally advanced or metastatic breast cancer;", " demonstrated resistance to anthracycline;", " >=2 regimens of chemotherapy for advanced/metastatic disease.", "Exclusion Criteria:", " previous treatment with Xeloda, continuous 5-fluorouracil infusion, or other oral fluoropyrimidines;", " previous treatment with paclitaxel or docetaxel for advanced/metastatic disease." ]

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

[ "Inclusion Criteria:", " Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)", " Unifocal or multifocal but in same quarter", " Size < 5cm clinically palpable or not", " Clinically or ultrasound axillary N0", " Isotopic sentinel node detection", " Adult patient", " Signed informed consent by patient or legally responsable authority", " Patient registered to a social security system", " No surgical contra-indication", "Exclusion Criteria:", " Mammary carcinoma recurrence", " Previous same side mammary reduction", " Previous lumpectomy", " Contra-indication to surgery", " Pregnant or breast feeding patient", " Denial of participation" ]

[ "Inclusion Criteria:", " Histologically documented, locally advanced, or metastatic breast cancer; measurable and/or non-measureable but evaluable disease is permitted", " HER2-positive disease", " History of prior trastuzumab therapy", " Life expectancy 90 days as assessed by the investigator", " Negative urine pregnancy test 72 hours prior to Cycle 1 Day 1 for all women of childbearing potential", " For patients of childbearing potential, agreement to use one highly effective form of contraception or two effective forms of contraception for the duration of the study treatment(s) and for 4 months after the last dose of T-DM1 or 6 months after the last dose of pertuzumab, if applicable", "Exclusion Criteria:", " Any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biologic therapy for the treatment of breast cancer within 2 weeks of the first study treatment", " Prior T-DM1 or pertuzumab therapy", " History of intolerance (such as Grade 3-4 infusion reaction) and/or adverse events related to trastuzumab", " Grade 2 (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3) peripheral neuropathy at the time of or within 3 weeks prior to the first study treatment", " Brain metastases that are untreated or progressive or have required any type of therapy, including radiation, surgery, and/or steroids, to control symptoms from brain metastases within 60 days prior to the first study treatment", " History of cardiac disease, unstable angina, symptomatic congestive heart failure (CHF) (Class II per the New York Heart Associate [NYHA] guidelines), myocardial infarction, or ventricular arrhythmia 6 months prior to Cycle 1, Day 1", " Implantable pacemaker or automatic implantable cardioverter defibrillator", " Congenital long QT syndrome or family history of long QT syndrome", " Current uncontrolled hypertension", " Current treatment with medications that alter cardiac conduction (e.g., digitalis, beta-blockers, or calcium channel blockers) or medications that are generally accepted to have a risk of causing torsades de pointes (TdP)", " Current known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus", " Major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment" ]

[ "INTERVENTION 1: ", " Exemestane", " exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.", " Exemestane: exemestane 25 mg by mouth (PO) every day for two years", " Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years", " Vitamin D: Vitamin D 400 international units PO every day x 2 years" ]

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

[ "Adverse Events 1:", " Total: 15/31 (48.39%)", " Intracardiac Thrombus 1/31 (3.23%)", " Diarrhoea 2/31 (6.45%)", " Nausea 2/31 (6.45%)", " Vomiting 2/31 (6.45%)", " Ascites 0/31 (0.00%)", " Ileus 1/31 (3.23%)", " Small Intestinal Obstruction 1/31 (3.23%)", " Multi-Organ Failure 0/31 (0.00%)", " Sepsis 1/31 (3.23%)", " Weight Decreased 1/31 (3.23%)", " Dehydration 2/31 (6.45%)", " Hypokalaemia 0/31 (0.00%)", "Adverse Events 2:", " Total: 4/31 (12.90%)", " Intracardiac Thrombus 0/31 (0.00%)", " Diarrhoea 0/31 (0.00%)", " Nausea 0/31 (0.00%)", " Vomiting 0/31 (0.00%)", " Ascites 1/31 (3.23%)", " Ileus 0/31 (0.00%)", " Small Intestinal Obstruction 0/31 (0.00%)", " Multi-Organ Failure 1/31 (3.23%)", " Sepsis 0/31 (0.00%)", " Weight Decreased 0/31 (0.00%)", " Dehydration 0/31 (0.00%)", " Hypokalaemia 1/31 (3.23%)" ]

[ "INTERVENTION 1: ", " Active Medicine Group", " risedronate 35 mg weekly", "INTERVENTION 2: ", " Placebo Group", " Received placebo medication once weekly" ]

[ "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: ", " Treatment (Biological Therapy, Chemo)", " Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions QD on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.", " imiquimod: Given topically", " Abraxane: Given IV", " laboratory biomarker analysis: Correlative studies", " RNA analysis: Correlative studies", " immunoenzyme technique: Correlative studies" ]

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

[ "INTERVENTION 1: ", " LA-EP2006", " During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.", " LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.", "INTERVENTION 2: ", " Neulasta®", " During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.", " Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." ]

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

[ "INTERVENTION 1: ", " Arm I (Lymphedema Education)", " Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months.", "INTERVENTION 2: ", " Arm II (Lymphedema Education, Physical Therapy)", " Patients receive lymphedema education and complete physical assessments and questionnaires as in Arm I. Patients also complete a personalized physical therapy intervention, receive a refrigerator magnet, and a 15-minute video that reinforces information and exercises." ]

[ "Inclusion Criteria:", " Histologically confirmed HER2 overexpressing (IHC 3+ and/or FISH +) metastatic breast cancer with measurable disease. Patients with either HER2 3+ positive tumors by immunohistochemistry (Dako Herceptest®) or gene amplification (> 2 copies) by fluorescence in-situ hybridation (FISH) are eligible.", " Progression following at least 8 weeks of standard doses of Herceptin or a Herceptin containing regimen.", " Off Herceptin for a minimum of 2 weeks.", " Patients must have measurable disease as defined by RECIST guidelines (the lesion that will be biopsied on study cannot be the only measurable lesion).", " Life expectancy > 3 months", " Age 18 years", " ECOG performance status 2", " Adequate bone marrow function as indicated by the following:", " ANC 1500/µL", " Platelets 100,000/µL", " Hemoglobin 9 g/dL", " Adequate liver function, as indicated by bilirubin 1.5 x ULN, AST or ALT <2x ULN.", " Adequate renal function, as indicated by creatinine <1.5 x upper limit of normal (ULN)", " Ability to understand and the willingness to sign a written informed consent.", " Adequate birth control: Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Pregnant and nursing patients are excluded because the effects of the combination of Rapamycin on a fetus or nursing child are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.", " Fasting serum cholesterol <350 mg/d L and triglycerides < 400 mg/ d L.", " Biopsy is required but patients or physicians may opt out of this part of the trial if sufficient justification is provided. Justification must be provided to the PI in writing indicating excessive physical risk or psychological trauma if biopsy is undertaken.", "Exclusion Criteria:", " Active infection or treatment for systemic infections within 14 days of enrollment", " Patients with active brain metastases requiring treatment, inclusive but not limited to surgery, radiation, and corticosteroids (patients with asymptomatic non- progressing brain metastasis who have completed treatment 30 days before enrollment and without evidence of progression on a post treatment MRI may be considered for the study).", " Pregnant or lactating women", " Prior chemotherapy within the last 4 weeks (last 6 weeks for nitrosureas/mitomycin)", " Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).", " Prior therapy with rapamycin, rapamycin analogs, or experimental agents targeting mTOR.", " Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.", " Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower", " Hypersensitivity to trial medications", " Patients may not be receiving any other investigational agents within 30 days before enrollment.", " Uncontrolled intercurrent illness 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.", " Pregnant women are excluded from this study because the investigational agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated.", " HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents.", " Use of all herbal and alternative medications within 4 weeks. All herbal and alternative medications should be discontinued while on study, these include but not limited to: Hydrastis canadensis (goldenseal) - Uncaria tomentosa (cat's claw) - Echinacea angustifolia roots - trifolium pratense (wild cherry) - matricaria chamomila (chamomile) - Glycyrrhiza glabra (licorice) - dillapiol - naringenim.", " Use of any of these medications within 4 weeks; cyclosporine, diltiazen, ketoconazole, rifampin, fluconazole, delavirdine, nicardipine, pioglitazone, and sulfonamides, erythromycin, clarithromycin, itraconazole, erythromycin, metoclopramide, nevirapine, phenobarbital, phenytoin, indinavir, fosamprenavir, nefazadone, St Johns Wort.", " Consumption of grapefruit juice is prohibited during the study.", " Use of warfarin (Coumadin), immunosuppressive agents or chronic oral, intravenous or topical steroid" ]

[ "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: 27/41 (65.85%)", " Febrile Neutropenia 4/41 (9.76%)", " Neutropenia 1/41 (2.44%)", " Deep Vein Thrombosis 1/41 (2.44%)", " Pulmonary embolism 1/41 (2.44%)", " Femoral Artery occlusion 1/41 (2.44%)", " Abdominal Pain 2/41 (4.88%)", " Constipation 1/41 (2.44%)", " Fatigue 2/41 (4.88%)", " Headache 1/41 (2.44%)", " Nausea 1/41 (2.44%)", " Cellulitis 1/41 (2.44%)", " Muscular Weakness 1/41 (2.44%)" ]

[ "Adverse Events 1:", " Total: 15/31 (48.39%)", " Intracardiac Thrombus 1/31 (3.23%)", " Diarrhoea 2/31 (6.45%)", " Nausea 2/31 (6.45%)", " Vomiting 2/31 (6.45%)", " Ascites 0/31 (0.00%)", " Ileus 1/31 (3.23%)", " Small Intestinal Obstruction 1/31 (3.23%)", " Multi-Organ Failure 0/31 (0.00%)", " Sepsis 1/31 (3.23%)", " Weight Decreased 1/31 (3.23%)", " Dehydration 2/31 (6.45%)", " Hypokalaemia 0/31 (0.00%)", "Adverse Events 2:", " Total: 4/31 (12.90%)", " Intracardiac Thrombus 0/31 (0.00%)", " Diarrhoea 0/31 (0.00%)", " Nausea 0/31 (0.00%)", " Vomiting 0/31 (0.00%)", " Ascites 1/31 (3.23%)", " Ileus 0/31 (0.00%)", " Small Intestinal Obstruction 0/31 (0.00%)", " Multi-Organ Failure 1/31 (3.23%)", " Sepsis 0/31 (0.00%)", " Weight Decreased 0/31 (0.00%)", " Dehydration 0/31 (0.00%)", " Hypokalaemia 1/31 (3.23%)" ]

[ "Adverse Events 1:", " Total: 17/65 (26.15%)", " Febrile neutropenia 3/65 (4.62%)", " Neutropenia 2/65 (3.08%)", " Pancytopenia 1/65 (1.54%)", " Thrombocytopenia 1/65 (1.54%)", " Cardiac arrest 2/65 (3.08%)", " Myocardial infarction 1/65 (1.54%)", " Diarrhoea 5/65 (7.69%)", " Stomatitis 1/65 (1.54%)", " Vomiting 2/65 (3.08%)", " Fatigue 1/65 (1.54%)", " Jaundice 1/65 (1.54%)", " Neutropenic infection 2/65 (3.08%)" ]

[ "Inclusion Criteria", " Pathologically confirmed diagnosis of invasive breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy;", " Tumor size >2cm, measured on imaging or estimated by physical exam;", " No contraindications for primary chemotherapy;", " Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;", " Age 18 years or older;", " ECOG Performance Status 2 (Karnofsky 60%; see Appendix II);", " Normal organ and marrow function as follows:", " leukocytes 3,000/μl;", " absolute neutrophil count 1,500/μl;", " platelets 100,000/μl;", " total bilirubin within normal institutional limits;", " AST(SGOT)/ALT(SGPT) 2.5 times the institutional upper limit of normal;", " creatinine within normal institutional limits; OR", " creatinine clearance 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal;", " If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional Standard of Care (SOC), and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;", " Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines;", " Exclusion Criteria", " Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy;", " Uncontrolled intercurrent illness 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;", " Medically unstable;", " Under age 18;", " Pregnant or nursing;", " Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years." ]

[ "Inclusion Criteria:", " Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)", " Histological confirmation of Breast Cancer with documented ER+ receptor status", " Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL", " Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.", " Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits", "Exclusion Criteria:", " Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.", " More than 1 prior regimen of chemotherapy for breast cancer", " ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction", " History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.", " Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks" ]

[ "Adverse Events 1:", " Total: 2/35 (5.71%)", " Gastroesophageal reflux disease * 1/35 (2.86%)", " Ductal carcinoma in situ * 1/35 (2.86%)" ]

[ "Adverse Events 1:", " Total: 22/41 (53.66%)", " Anemia 1/41 (2.44%)", " Dyspepsia 1/41 (2.44%)", " Mucositis oral 1/41 (2.44%)", " Nausea 3/41 (7.32%)", " Vomiting 1/41 (2.44%)", " Pain 3/41 (7.32%)", " Allergic reaction 1/41 (2.44%)", " Infections and infestations - Other, specify: [1]1/41 (2.44%)", " Vascular access complication 3/41 (7.32%)", " Alanine aminotransferase increased 1/41 (2.44%)" ]

[ "Inclusion Criteria:", " Primary breast cancer without known extension beyond the breast and axillary nodes (i.e. believed to be Tumor Stage 1-3, Nodes 0-2)", " Scheduled for unilateral or bilateral mastectomy with or without implant (isolated \"lumpectomy\" will not qualify)", " Isolated \"lumpectomy\" with axillary node dissection (anticipated removal of at least five nodes)", " Written informed consent, including willingness to be randomized to morphine or regional analgesia", "Exclusion Criteria:", " Previous surgery for breast cancer (except diagnostic biopsies)", " Inflammatory breast cancer", " Age < 18 or > 85 years old", " Scheduled free flap reconstruction", " ASA Physical Status 4", " Any contraindication to epidural or paravertebral anesthesia and analgesia (including coagulopathy, abnormal anatomy)", " Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine", " Other cancer not believed by the attending surgeon to be in long-term remission", " Systemic disease believed by the attending surgeon to present 25% two-year mortality" ]

[ "Inclusion Criteria:", " New diagnosis of breast cancer", " New diagnosis if a previous breast cancer patient with negative surgical margins", " Patients willing to sign a written informed consent form", "Exclusion Criteria:", " High risk benign lesions as the primary pathology diagnosis" ]

[ "Inclusion Criteria:", " History of ductal carcinoma in situ, lobular carcinoma in situ or stages 1-3 breast cancer", " Not currently receiving chemotherapy or hormonal therapy", " Postmenopausal", "Exclusion Criteria:", " Stage IV breast cancer or systemic recurrences", " Prior malignancies of any type other than breast cancer, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix", " Use of adjuvant hormonal therapy, oral estrogen or progesterone replacement therapy, lutenizing hormone releasing hormone agonists currently or within the past 60 days", " Concomitant use of beta-blockers", " Concomitant nightly use of sleep aids at bedtime", " Working more than one overnight shift per month on a regular basis", " Concomitant use of postmenopausal hormone replacement therapy", " Concomitant use of black cohosh, flaxseed or soy in pill or supplement form", " Use of any type of oral melatonin supplementation within the past 30 days", " Use of warfarin (coumadin) within the past 30 days", " Active seizure disorder requiring the use of daily anti-epileptic medication" ]

[ "Adverse Events 1:", " Total: 1/6 (16.67%)", " Goitre 0/6 (0.00%)", " Haemorrhoid Operation 0/6 (0.00%)", " Sciatica 0/6 (0.00%)", " Renal Failure 0/6 (0.00%)", " Varicose Vein 1/6 (16.67%)", "Adverse Events 2:", " Total: 2/7 (28.57%)", " Goitre 1/7 (14.29%)", " Haemorrhoid Operation 1/7 (14.29%)", " Sciatica 1/7 (14.29%)", " Renal Failure 1/7 (14.29%)", " Varicose Vein 0/7 (0.00%)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS)", " PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.", " Time frame: Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)", "Results 1: ", " Arm/Group Title: Trastuzumab + Lapatinib", " Arm/Group Description: Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.", " Overall Number of Participants Analyzed: 146", " Median (95% Confidence Interval)", " Unit of Measure: weeks 12.0 (8.1 to 16.0)", "Results 2: ", " Arm/Group Title: Lapatinib", " Arm/Group Description: Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.", " Overall Number of Participants Analyzed: 145", " Median (95% Confidence Interval)", " Unit of Measure: weeks 8.1 (7.6 to 9.0)" ]

[ "Outcome Measurement: ", " Time to Progression as Evaluated by the Investigator", " Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.", " Time frame: Randomization until the date of disease progression or death (average of 26 weeks)", "Results 1: ", " Arm/Group Title: Lapatinib With Paclitaxel", " Arm/Group Description: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.", " Overall Number of Participants Analyzed: 291", " Median (Inter-Quartile Range)", " Unit of Measure: weeks 29.0 (13.9 to 46.9)", "Results 2: ", " Arm/Group Title: Placebo With Paclitaxel", " Arm/Group Description: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.", " Overall Number of Participants Analyzed: 288", " Median (Inter-Quartile Range)", " Unit of Measure: weeks 22.9 (12.0 to 38.3)" ]

[ "Outcome Measurement: ", " Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) 10", " Overall survival (OS) was defined as the time from randomization to death due to any cause.", " Time frame: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)", "Results 1: ", " Arm/Group Title: Pembrolizumab", " Arm/Group Description: Participants received pembrolizumab 200 mg IV every Q3W for up to 35 administrations (up to ~2 years).", " Overall Number of Participants Analyzed: 96", " Median (95% Confidence Interval)", " Unit of Measure: Months 12.7 (9.9 to 16.3)", "Results 2: ", " Arm/Group Title: Chemotherapy", " Arm/Group Description: Participants received capecitabine, eribulin, gemcitabine, or vinorelbine as single agent chemotherapy chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with local regulations and guidelines.", " Overall Number of Participants Analyzed: 98", " Median (95% Confidence Interval)", " Unit of Measure: Months 11.6 (8.3 to 13.7)" ]

[ "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%)" ]

[ "INTERVENTION 1: ", " IPAS", " Once the patient recorded in the trial, and after completion of a post-implant dosimetry scanner to analyze the dose distribution within the target volume and organs at risk, the patient is treated by irradiation and partial accelerated breast brachytherapy using high dose rate, delivering a total dose of 16 Gy in one fraction", "IPAS" ]

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

[ "Adverse Events 1:", " Total: 15/131 (11.45%)", " Disseminated intravascular coagulation 1/131 (0.76%)", " Febrile neutropenia 5/131 (3.82%)", " Hemoglobin decreased 7/131 (5.34%)", " Lymphatics 1/131 (0.76%)", " Transfusion: pRBCs 0/131 (0.00%)", " Arrhythmia supraventricular 0/131 (0.00%)", " Cardiac disorder 1/131 (0.76%)", " Edema 0/131 (0.00%)", " Left ventricular failure 0/131 (0.00%)", " Myocardial ischemia 1/131 (0.76%)", "Adverse Events 2:", " Total: 17/181 (9.39%)", " Disseminated intravascular coagulation 0/181 (0.00%)", " Febrile neutropenia 1/181 (0.55%)", " Hemoglobin decreased 13/181 (7.18%)", " Lymphatics 0/181 (0.00%)", " Transfusion: pRBCs 1/181 (0.55%)", " Arrhythmia supraventricular 1/181 (0.55%)", " Cardiac disorder 0/181 (0.00%)", " Edema 0/181 (0.00%)", " Left ventricular failure 1/181 (0.55%)", " Myocardial ischemia 0/181 (0.00%)" ]

[ "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: ", " Progression-Free Survival (PFS)", " PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.", " Time frame: Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)", "Results 1: ", " Arm/Group Title: Trastuzumab + Lapatinib", " Arm/Group Description: Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.", " Overall Number of Participants Analyzed: 146", " Median (95% Confidence Interval)", " Unit of Measure: weeks 12.0 (8.1 to 16.0)", "Results 2: ", " Arm/Group Title: Lapatinib", " Arm/Group Description: Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.", " Overall Number of Participants Analyzed: 145", " Median (95% Confidence Interval)", " Unit of Measure: weeks 8.1 (7.6 to 9.0)" ]

[ "Outcome Measurement: ", " Time to Progression as Evaluated by the Investigator", " Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.", " Time frame: Randomization until the date of disease progression or death (average of 26 weeks)", "Results 1: ", " Arm/Group Title: Lapatinib With Paclitaxel", " Arm/Group Description: Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.", " Overall Number of Participants Analyzed: 291", " Median (Inter-Quartile Range)", " Unit of Measure: weeks 29.0 (13.9 to 46.9)", "Results 2: ", " Arm/Group Title: Placebo With Paclitaxel", " Arm/Group Description: Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.", " Overall Number of Participants Analyzed: 288", " Median (Inter-Quartile Range)", " Unit of Measure: weeks 22.9 (12.0 to 38.3)" ]

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

[ "Adverse Events 1:", " Total: 6/110 (5.45%)", " Sudden death unexplained 1/110 (0.91%)", " General body pain 1/110 (0.91%)", " Lymphangitis 1/110 (0.91%)", " Femur fracture 1/110 (0.91%)", " Parathyroid adenoma 1/110 (0.91%)", " Depression worsened 1/110 (0.91%)", " Calculus urinary bladder 1/110 (0.91%)", " Pneumopathy 1/110 (0.91%)" ]

[ "Adverse Events 1:", " Total: 4/26 (15.38%)", " Disseminated intravascular coagulation 1/26 (3.85%)", " Cardiac failure congestive 1/26 (3.85%)", " Breast cellulitis 1/26 (3.85%)", " Cellulitis 1/26 (3.85%)", " Acute myeloid leukaemia 1/26 (3.85%)", " Seizure 0/26 (0.00%)", " Pulmonary embolism 1/26 (3.85%)", "Adverse Events 2:", " Total: 2/24 (8.33%)", " Disseminated intravascular coagulation 0/24 (0.00%)", " Cardiac failure congestive 0/24 (0.00%)", " Breast cellulitis 0/24 (0.00%)", " Cellulitis 1/24 (4.17%)", " Acute myeloid leukaemia 0/24 (0.00%)", " Seizure 1/24 (4.17%)", " Pulmonary embolism 0/24 (0.00%)" ]

[ "Adverse Events 1:", " Total: 22/123 (17.89%)", " Cardiac Ischemia/Infarction [1]1/123 (0.81%)", " Pain - Chest 2/123 (1.63%)", " Dehydration 2/123 (1.63%)", " Death [2]1/123 (0.81%)", " Weakness 1/123 (0.81%)", " Pain - Liver 1/123 (0.81%)", " Infection - Skin [3]3/123 (2.44%)", " Infection - Gastrointestinal [4]1/123 (0.81%)", " Infection - Vein [5]2/123 (1.63%)", " Infection - Pneumonia 1/123 (0.81%)" ]

[ "Adverse Events 1:", " Total: 14/67 (20.90%)", " Febrile neutropenia 21/67 (1.49%)", " Leukopenia 21/67 (1.49%)", " Neutropenia 21/67 (1.49%)", " Macular hole 21/67 (1.49%)", " Diarrhoea 22/67 (2.99%)", " Abdominal pain 21/67 (1.49%)", " Abdominal pain upper 21/67 (1.49%)", " Enteritis 21/67 (1.49%)", " Gastritis 21/67 (1.49%)", " Nausea 21/67 (1.49%)", " Vomiting 21/67 (1.49%)", " Pneumonia 21/67 (1.49%)", "Adverse Events 2:", " Total: 1/10 (10.00%)", " Febrile neutropenia 20/10 (0.00%)", " Leukopenia 20/10 (0.00%)", " Neutropenia 20/10 (0.00%)", " Macular hole 20/10 (0.00%)", " Diarrhoea 20/10 (0.00%)", " Abdominal pain 20/10 (0.00%)", " Abdominal pain upper 20/10 (0.00%)", " Enteritis 20/10 (0.00%)", " Gastritis 20/10 (0.00%)", " Nausea 20/10 (0.00%)", " Vomiting 20/10 (0.00%)", " Pneumonia 20/10 (0.00%)" ]

[ "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" ]

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

[ "Inclusion Criteria:", " Female patients with histological or cytological proven diagnosis of breast cancer", " Stage IV disease", " Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale", " Patients had to have previously received anthracycline based regimens as a adjuvant therapy or neo-adjuvant chemotherapy and then progressed and developed metastatic disease", " Adequate organ function", "Exclusion Criteria:", " Prior chemotherapy for metastatic disease", " Previous radiation therapy is allowed but must not have included whole pelvis radiation", " Known or suspected brain metastasis. Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator", " Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy and immunotherapy (including trastuzumab (Herceptin))", " Peripheral neuropathy of Common Toxicity Criteria (CTC) Grade greater than 1. History of significant neurological or mental disorder, including seizures or dementia" ]

[ "INTERVENTION 1: ", " Arm Compression Only", "[Not Specified]", "INTERVENTION 2: ", " Arm, Trunck and Chest Compression", "[Not Specified]" ]

[ "INTERVENTION 1: ", " Single Arm Institution, Open Label, Phase II", " Patients will received 825 mg/m2 bid of capecitabine. One of the two daily doses of capecitabine will be taken 2 hours before receiving radiotherapy. Capecitabine will be administered when patients receives radiation therapy. Radiation therapy doses will be 50-57 Gy to the initial clinical target volume." ]

[ "INTERVENTION 1: ", " CMRM Versus UMRM", "[Not Specified]" ]

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

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

[ "Adverse Events 1:", " Total: 102/403 (25.31%)", " Anaemia 1/403 (0.25%)", " Febrile neutropenia 1/403 (0.25%)", " Granulocytopenia 0/403 (0.00%)", " Neutropenia 1/403 (0.25%)", " Thrombocytopenia 1/403 (0.25%)", " Cardiac failure 1/403 (0.25%)", " Vertigo 1/403 (0.25%)", " Hypercalcaemia of malignancy 0/403 (0.00%)", " Vision blurred 1/403 (0.25%)", " Abdominal discomfort 0/403 (0.00%)", " Abdominal pain 4/403 (0.99%)", "Adverse Events 2:", " Total: 41/184 (22.28%)", " Anaemia 2/184 (1.09%)", " Febrile neutropenia 7/184 (3.80%)", " Granulocytopenia 1/184 (0.54%)", " Neutropenia 2/184 (1.09%)", " Thrombocytopenia 1/184 (0.54%)", " Cardiac failure 0/184 (0.00%)", " Vertigo 0/184 (0.00%)", " Hypercalcaemia of malignancy 1/184 (0.54%)", " Vision blurred 0/184 (0.00%)", " Abdominal discomfort 1/184 (0.54%)", " Abdominal pain 3/184 (1.63%)" ]

[ "INTERVENTION 1: ", " IUS Alone", "IUS alone imaging", "INTERVENTION 2: ", " Imagio (IUS+OA)", "IUS+OA imaging" ]

[ "INTERVENTION 1: ", " All Study Participants: Patient Assisted Compression", " All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.", " Patient-Assisted Compression (PAC): The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.", "INTERVENTION 2: ", " All Study Participants: Technologist Compression", " All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.", " Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site." ]

[ "Inclusion Criteria:", " Age 52-75 years old;", " Identification as Latina/Hispanic/Chicana female;", " Residence in Pilsen, Little Village, East Side or South Chicago;", " No history of health volunteerism;", " No history of breast cancer; and", " Lack of a mammogram within the last two years", "Exclusion Criteria:", " Not meeting all inclusion criteria;", " Women will be excluded if they participated in formative focus groups" ]

[ "Inclusion Criteria:", " Female patients with histologically or cytologically confirmed carcinoma of the breast. Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.", " Patients with locally advanced or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least one of which was administered for treatment of locally advanced or metastatic disease.", " Prior therapy must be documented by the following criteria prior to entry onto study:", " Regimens must have included an anthracycline (eg, doxorubicin, epirubicin), a taxane (eg, paclitaxel, docetaxel) and capecitabine in any combination or order.", " One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy.", " Patients with human epidermal growth factor receptor 2 (HER2/neu) over-expressing tumors must additionally have been treated with trastuzumab.", " Patients with estrogen receptor-expressing tumors may have additionally been treated with estrogen-specific therapy.", " Prior hormonal therapy, biological therapy, (eg, trastuzumab, bevacizumab), or immunotherapy, is not to be counted as one of the 2 to 5 prior chemotherapy regimens allowed. However, hormonal therapy must be discontinued one week before administration of E7389, and biological therapy must be discontinued two weeks before E7389 administration.", " Patients who are being treated with bisphosphonates when they enter the study are allowed to continue the medication as long as the dosing does not change. In case a change in dosing is deemed necessary, the case needs to be discussed with the Sponsor.", " Progression on or within six months of the last regimen for advanced disease, documented by the following:", " The dates of treatment, doses, outcome of therapy and the reason for discontinuation of prior anthracycline, taxane, capecitabine, and trastuzumab therapy must be provided.", " Prior to entry onto the study, information ensuring that the last therapy fulfills eligibility criteria is required, which includes progression while receiving this last prior chemotherapy regimen, or within six months of receiving that therapy.", " Chemotherapy medication administration sheets or other official medical/hospital records indicating type and dates of chemotherapy must be available for inspection, and one of the following as a reason for discontinuation of medication is required: radiographic evidence of progression, or doctor's office or hospitalization notes documenting radiologic progression, clinically documented increase in tumor burden, and/or increase in tumor-specific markers.", " Patients with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, defined as at least one lesion that can be accurately measured in at least one diameter (at least 10 mm in longest diameter [LD] by spiral computer tomography [CT] scan), or at least 20 mm by standard techniques. If the only measurable lesion is a lymph node, it must measure at least 20 mm in LD. If a single lesion is identified as the target lesion, a biopsy or aspiration with cytological or histological confirmation of the diagnosis of breast carcinoma is required.", " Resolution of all chemotherapy or radiation-related toxicities to less than Grade 2 severity, except for stable sensory neuropathy Grade 2 and alopecia.", " Age >= 18 years.", " Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.", " Life expectancy of 3 months.", " Adequate renal function as evidenced by serum creatinine 2.0 mg/dL or calculated creatinine clearance 40 mL/minute (min) per the Cockcroft and Gault formula.", " Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) 1.5 x 10^9/L hemoglobin 10.0 g/dL (acceptable if it is corrected by therapeutic intervention or transfusional support), and platelet count 100 x 10^9/L.", " Adequate liver function as evidenced by bilirubin 1.5 mg/dL and alkaline phosphatase, alanine transaminase (ALT), and aspartate transaminase (AST) 3 times the upper limits of normal (ULN) (in the case of liver metastases 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.", " Willing and able to complete the European Organization for Research on the Treatment of Cancer (EORTC) quality of life assessment, Analgesic Diary, and Pain Visual Analog Scale (VAS).", " Willing and able to comply with the study protocol for the duration of the study.", " Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.", "Exclusion Criteria:", " Patients must not have received chemotherapy, radiation, or biologic therapy within two weeks, hormonal therapy within one week, or trastuzumab within three weeks, before E7389 treatment start.", " Patients must not have received radiation therapy encompassing > 30% of marrow (a lesion that has been irradiated cannot be used as a target lesion, unless it has progressed after the irradiation).", " Patients must not have pre-existing neuropathy > Grade 2.", " Patients must not have participated in a prior E7389 clinical trial." ]

[ "Adverse Events 1:", " Total: 1/25 (4.00%)", " Diarrhoea 0/25 (0.00%)", " Breast abscess 0/25 (0.00%)", " Breast cellulitis 0/25 (0.00%)", " Syncope 1/25 (4.00%)", "Adverse Events 2:", " Total: 1/20 (5.00%)", " Diarrhoea 1/20 (5.00%)", " Breast abscess 1/20 (5.00%)", " Breast cellulitis 1/20 (5.00%)", " Syncope 0/20 (0.00%)" ]

[ "Inclusion Criteria:", " All study patients must have histologically confirmed invasive adenocarcinoma of the breast. Their breast cancer must be resectable clinical stage I or II breast cancer as defined by the current AJCC TNM Staging System (Greene FL, Page DL, Fleming ID, et al.: editors. AJCC cancer staging manual, 6th edition. New York: Springer; 2002).", " All patients must be able to and give informed consent indicating they are aware of the investigational nature of this treatment, prior to entry into the study.", " All subjects must be Age >18 years.", " All subject must have adequate hepatic and renal function documented prior to study entry to include: hepatic transaminases (AST or ALT) 1.5 times the upper limits of normal, total bilirubin 1.5 times the upper limits of normal, serum creatinine 1.5 times the upper limit of normal or eCRCl 60 mL/min.", "Exclusion criteria:", " Patients who have received prior or be receiving radiation therapy for their breast cancer will be excluded.", " Patients who have received prior chemotherapy or receiving chemotherapy or hormonal therapy for their breast cancer will not be included.", " Women must be surgically sterilized or post-menopausal or women of childbearing potential must be using an adequate method of contraception. Women of childbearing potential must be using at least one of the following: oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or have a partner that is sterile (e.g., vasectomy). Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. Women who are pregnant or breast-feeding and women of childbearing potential not using an adequate method of birth control will be excluded.", " Patients with gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, or prior surgical procedures affecting nutrient /drug absorption will be excluded.", " A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment will be excluded. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, and congestive heart failure, myocardial infarction within the previous 3 months or serious cardiac arrhythmias will be excluded. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol will be excluded." ]

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

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

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

[ "Inclusion Criteria:", " New diagnosis of breast cancer", " New diagnosis if a previous breast cancer patient with negative surgical margins", " Patients willing to sign a written informed consent form", "Exclusion Criteria:", " High risk benign lesions as the primary pathology diagnosis" ]

[ "Adverse Events 1:", " Total: 0/23 (0.00%)", " LEFT VENTRICULAR SYSTOLIC DYSFUNCTION *0/23 (0.00%)", " NAUSEA *0/23 (0.00%)", " VOMITING *0/23 (0.00%)", " BILIRUBIN (HYPERBILIRUBINEMIA) *0/23 (0.00%)", " INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E *0/23 (0.00%)", " NEUTROPHILS/GRANULOCYTES (ANC/AGC) *0/23 (0.00%)" ]

[ "Inclusion Criteria:", " Women 18 years of age or older", " History of invasive ER+ or PR+ breast cancer treated with at least 4.5 years of tamoxifen", " No current evidence of recurrent invasive disease or metastatic disease. Patients may have a history of bilateral breast cancer", " Premenopausal (estradiol level in premenopausal range, >20pg/ml, within the prior 28 days)", " Liver function tests and creatinine <2.5 times the upper limit of normal within the 28 days prior to enrollment", " ECOG Performance Status 0-1", " Must agree to use non-hormonal contraception (condoms, diaphragm, IUD, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped", " Negative pregnancy test within 14 days prior to enrollment", " Patient must be able to speak, read and write in English", "Exclusion Criteria:", " Previous treatment with an oral or IV bisphosphonate in the prior two years", " History of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix", " Women with evidence of current local recurrence or metastatic breast cancer", " Pregnant women", " Nursing women", " Women who are currently taking tamoxifen and are unwilling to stop this medication", " Women with a known deleterious BRCA 1 or BRCA 2 mutation" ]

[ "Inclusion Criteria:", " Females greater than or equal to ( ) 18 years of age, with histologically-confirmed HER2-positive breast cancer", " Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease", " Less than or equal to ( ) 3 chemotherapy regimens prior to study entry", " Last trastuzumab dose 9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and 4 weeks for participants receiving pertuzumab monotherapy", " Left ventricular ejection fraction 55% at study entry", "Exclusion Criteria:", " Previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab", " Brain metastases", " History of any cardiac adverse event related to trastuzumab therapy", " Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix" ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed primary adenocarcinoma of the breast", " Locally recurrent or metastatic disease", " Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past", " Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm by conventional techniques or as > 10 mm by spiral CT scan.", " No known CNS disease", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", "Inclusion criteria:", " Postmenopausal status not specified", " ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%", " Life expectancy > 12 weeks", " WBC 3,000/mcL", " Absolute neutrophil count 1,500/mcL", " Platelet count 100,000/mcL", " Total bilirubin normal", " AST and ALT 2.5 times upper limit of normal (ULN)", " Alkaline phosphatase 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)", " Creatinine 1.5 mg/dL", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix", "Exclusion criteria:", " Pre-existing neuropathy grade 1", " Uncontrolled intercurrent illness including, but not limited to, any of the following:", " Ongoing or active infection", " Symptomatic congestive heart failure", " Unstable angina pectoris", " Cardiac arrhythmia", " Serious, non-healing wound, ulcer, or bone fracture", " Psychiatric illness/social situations that would limit compliance with study requirements", " Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)", " History of hypertensive crisis or hypertensive encephalopathy", " New York Heart Association class II-IV congestive heart failure", " History of myocardial infarction or unstable angina within the past 6 months", " History of stroke or transient ischemic attack within the past 6 months", " Significant vascular disease (e.g., aortic aneurysm, aortic dissection)", " Symptomatic peripheral vascular disease", " Evidence of bleeding diathesis or coagulopathy", " Significant traumatic injury within the past 28 days", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months", " Proteinuria, as demonstrated by either urine protein:creatinine ratio 1.0 OR urine dipstick for proteinuria 2+", " Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein 1g", " History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Recovered from all prior therapy", " No prior chemotherapy for locally recurrent or metastatic disease", " Prior neoadjuvant or adjuvant chemotherapy allowed", " More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device", " More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy", " More than 4 weeks since prior radiotherapy", " More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)", " At least 1 year since prior taxane regimen", " No other concurrent investigational agents", " Concurrent anticoagulation allowed, provided the following criteria are met:", " Stable dose of warfarin or low molecular weight heparin", " INR within desired range (2-3)", " No evidence of active bleeding or coagulopathy", " No concurrent combination antiretroviral therapy for HIV-positive patients", " No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy" ]

[ "Key Inclusion Criteria:", " - Women with locally advanced, recurrent, or metastatic breast cancer along with confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least one lesion 10 mm by CT or MRI that can be accurately measured in at least one dimension (CT scan slice thickness 5 mm) OR Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.", " Key Exclusion Criteria:", " - Patients who received more than one chemotherapy line. Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors." ]

[ "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)" ]

[ "Inclusion Criteria:", " Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent.", " Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale.", " One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment.", " One prior chemotherapy containing taxanes as (neo) adjuvant or palliative 1st-line treatment.", " Prior radiation therapy is allowed to less than 25% of the bone marrow. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.", " At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Positron emission tomography [PET] scans and ultrasounds may not be used.", " Antitumoral hormonal treatment must be discontinued prior to enrollment.", " Estimated life expectancy of at least 3 months.", " Participant compliance and geographic proximity that allow adequate follow-up.", " Adequate organ function", " Female participants of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.", " Participants must sign an informed consent document.", " Female participants must be at least 18 years of age.", "Exclusion Criteria:", " Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.", " Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine", " Have received more than one line of chemotherapy in Metastatic Breast Cancer. Participants having received more than one combination of anthracycline plus taxane.", " Are pregnant or breast-feeding.", " Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to complete the study.", " Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.", " Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam), unless the Creatinine Clearance is greater than or equal to 80 ml/min.", " Have central nervous system (CNS) metastases.", " Have clinically relevant (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry.", " Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.", " Concurrent administration of any other antitumor therapy." ]

[ "Adverse Events 1:", " Total: 81/353 (22.95%)", " Febrile neutropenia * 13/353 (3.68%)", " Anaemia * 21/353 (0.28%)", " Neutropenia * 25/353 (1.42%)", " Thrombocytopenia * 20/353 (0.00%)", " Hypercoagulation * 21/353 (0.28%)", " Leukopenia * 21/353 (0.28%)", " Atrial fibrillation * 1/353 (0.28%)", " Cardiac failure * 0/353 (0.00%)", " Cardiac failure congestive * 0/353 (0.00%)", " Myocardial infarction * 1/353 (0.28%)", "Adverse Events 2:", " Total: 86/361 (23.82%)", " Febrile neutropenia * 0/361 (0.00%)", " Anaemia * 25/361 (1.39%)", " Neutropenia * 20/361 (0.00%)", " Thrombocytopenia * 22/361 (0.55%)", " Hypercoagulation * 20/361 (0.00%)", " Leukopenia * 20/361 (0.00%)", " Atrial fibrillation * 0/361 (0.00%)", " Cardiac failure * 0/361 (0.00%)", " Cardiac failure congestive * 0/361 (0.00%)", " Myocardial infarction * 0/361 (0.00%)" ]

[ "Adverse Events 1:", " Total: 4/104 (3.85%)", " Neutropenia 1/104 (0.96%)", " Leukopenia 2/104 (1.92%)", " paranasal sinus reaction 1/104 (0.96%)", " cellulitis 1/104 (0.96%)", "Adverse Events 2:", " " ]

[ "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%)" ]

[ "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.)." ]

[ "Outcome Measurement: ", " Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study", " CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.", " Time frame: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression", "Results 1: ", " Arm/Group Title: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg", " Arm/Group Description: Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 46", " Measure Type: Number", " Unit of Measure: Percentage of participants 47.8 (32.9 to 63.1)", "Results 2: ", " Arm/Group Title: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg", " Arm/Group Description: Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 45", " Measure Type: Number", " Unit of Measure: Percentage of participants 71.1 (55.7 to 83.6)" ]

[ "Inclusion Criteria:", " Women aged 45-69, according to the target age of the screening centres involved;", " New invited women in mammography screening programme.", "Exclusion Criteria:", "None" ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed infiltrating breast cancer", " Clinical evidence of metastatic disease", " Measurable disease, defined as at least one measurable lesion per RECIST criteria", " No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly non-measurable lesions, including any of the following:", " Bone lesions", " Leptomeningeal disease", " Ascites", " Pleural/pericardial effusion", " Inflammatory breast disease", " Lymphangitis cutis/pulmonis", " Abdominal masses that are not confirmed and followed by imaging techniques", " Cystic lesions", " Patients with HER-2/neu positive tumors, must have received prior treatment with trastuzumab (Herceptin®) or have a contraindication for trastuzumab", " No evidence of active brain metastasis, including leptomeningeal involvement, on MRI or CT scan", " CNS metastasis controlled by prior surgery and/or radiotherapy allowed", " Must be asymptomatic for 2 months with no evidence of progression prior to study entry", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Menopausal status not specified", " Life expectancy 12 weeks", " ECOG performance status 0-1", " ANC 1,500/mm³", " Platelet count 100,000/mm³", " Hemoglobin 9.0 g/dL", " AST and ALT 2.5 times upper limit of normal (ULN)", " Alkaline phosphatase 2.5 times ULN", " Total bilirubin 1.5 times ULN", " Creatinine 1.5 mg/dL", " Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein", " Patients discovered to have 1+ proteinuria at baseline must demonstrate 24-hour urine protein < 1 g", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception during and for 30 days after completion of study therapy", " Able to complete questionnaires alone or with assistance", " No peripheral neuropathy > grade 1", " No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents", " No stage III or IV invasive, non-breast malignancy within the past 5 years", " No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix", " Patient must not be receiving other specific treatment for a prior malignancy", " No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on 2 occasions at least 5 minutes apart)", " Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for 3 different observations in 14 days", " No bleeding diathesis or uncontrolled coagulopathy", " No hemoptysis within the past 6 months", " No prior arterial or venous thrombosis within the past 12 months", " No history of cerebrovascular accident", " No history of hypertensive crisis or hypertensive encephalopathy", " No abdominal fistula or gastrointestinal perforation within the past 6 months", " No serious non-healing wound, ulcer, or fracture", " No clinically significant cardiac disease, defined as any of the following:", " Congestive heart failure", " Symptomatic coronary artery disease", " Unstable angina", " Cardiac arrhythmias not well controlled with medication", " Myocardial infarction within the past 12 months", " No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " No prior chemotherapy for metastatic disease", " May have received one prior adjuvant chemotherapy regimen", " Prior neoadjuvant chemotherapy allowed", " More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy", " Prior hormonal therapy in either adjuvant or metastatic setting allowed", " More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)", " Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed", " More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug", " More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)", " More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy", " More than 1 week since prior minor surgery (e.g., core biopsy)", " Placement of a vascular access device within 7 days is allowed", " More than 3 months since prior neurosurgery", " No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered", " Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed" ]

[ "Adverse Events 1:", " Total: 379/1288 (29.43%)", " Febrile neutropenia 84/1288 (6.52%)", " Neutropenia 69/1288 (5.36%)", " Leukopenia 8/1288 (0.62%)", " Anaemia 1/1288 (0.08%)", " Thrombocytopenia 4/1288 (0.31%)", " Pancytopenia 1/1288 (0.08%)", " Febrile bone marrow aplasia 1/1288 (0.08%)", " Atrial fibrillation 4/1288 (0.31%)", " Cardiac failure congestive 6/1288 (0.47%)", "Adverse Events 2:", " Total: 250/1271 (19.67%)", " Febrile neutropenia 59/1271 (4.64%)", " Neutropenia 38/1271 (2.99%)", " Leukopenia 1/1271 (0.08%)", " Anaemia 3/1271 (0.24%)", " Thrombocytopenia 0/1271 (0.00%)", " Pancytopenia 1/1271 (0.08%)", " Febrile bone marrow aplasia 0/1271 (0.00%)", " Atrial fibrillation 2/1271 (0.16%)", " Cardiac failure congestive 0/1271 (0.00%)" ]

[ "Adverse Events 1:", " Total: 15/148 (10.14%)", " Febrile neutropenia 1/148 (0.68%)", " Atrial fibrillation 2/148 (1.35%)", " Abdominal pain 1/148 (0.68%)", " Diarrhoea 1/148 (0.68%)", " Pyrexia 2/148 (1.35%)", " Cellulitis 1/148 (0.68%)", " Device related infection 2/148 (1.35%)", " Gastroenteritis viral 1/148 (0.68%)", " Gastrointestinal infection 1/148 (0.68%)", " Upper respiratory tract infection 1/148 (0.68%)" ]

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

[ "Outcome Measurement: ", " Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score.", " For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = [(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=[(SRG - BL)/BL]x100", " Time frame: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)", "Results 1: ", " Arm/Group Title: Fulvestrant", " Arm/Group Description: Fulvestrant 500 mg once monthly injection", " Overall Number of Participants Analyzed: 35", " Mean (Standard Error)", " Unit of Measure: Percentage change from baseline -37 (4)", "Results 2: ", " Arm/Group Title: Fulvestrant + Anastrozole", " Arm/Group Description: Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet", " Overall Number of Participants Analyzed: 31", " Mean (Standard Error)", " Unit of Measure: Percentage change from baseline -38 (5)" ]

[ "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)" ]

[ "Outcome Measurement: ", " Percentage of Participants With Overall Response Rate (ORR)", " Overall Response Rate (ORR) was defined as the proportion of patients whose best overall response was either complete response (CR) or partial response (PR) according to RECIST 1.0 for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions for a period of at least one month; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (ORR) = CR + PR. Only descriptive statistics.", " Time frame: From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 15 months", "Results 1: ", " Arm/Group Title: Everolimus + Letrozole", " Arm/Group Description: All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.", " Overall Number of Participants Analyzed: 43", " Measure Type: Number", " Unit of Measure: Percentage of Participants 37.2" ]

[ "INTERVENTION 1: ", " Arm Compression Only", "[Not Specified]", "INTERVENTION 2: ", " Arm, Trunck and Chest Compression", "[Not Specified]" ]

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

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast cancer, pre-operative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging", " Cohort 1: At least 2cm of residual disease in sum of diameters by clinical or radiographic findings following their preoperative chemotherapy", " Cohort 2: Patients who have not received preoperative chemotherapy must have at least 4cm of disease in the largest diameter by clinical or radiographic findings", " Prior therapy for Cohort 1 only: Must have completed preoperative (neoadjuvant) chemotherapy with either a standard regimen (containing an anthracycline and/or a taxane) or on a clinical trial", " HER2 positive tumors must have received at least one prior trastuzumab-based therapy, and may not receive concurrent trastuzumab therapy and vaccination", " Must initiate hormonal therapy (if indicated), including ovarian suppression, at least 4 weeks prior to initiation of vaccinations", " Must have completed definitive resection of primary tumor with adequated excision of gross disease. Surgery should have occured more than 28 days but within 12 weeks prior to enrollment", " May receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and aromatase inhibitors", " Must have had prior banked tumor of sufficient cellular yield for vaccination", " ECOG Performance Status 0 or 1", " 18 years of age or older", " Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy", " Adequate recovery from recent surgery and radiation therapy", "Exclusion Criteria:", " Uncontrolled active infection or illness", " Other medical or psychiatric illness or social situation that would limit study compliance", " Pregnancy or nursing mothers", " Evidence of HIV infection", " Previous participation in an adenovirus-based trial", " Concurrent invasive malignancies" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed invasive breast cancer, with stage IV disease", " Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 20mm with conventional techniques or as greater than or equal to 10mm with spiral CT scan.", " Primary tumor or metastasis must overexpress HER2", " Patient must have received 1-2 prior chemotherapeutic regiments for metastatic breast cancer and must have been off treatment for at least three weeks.", " Patient must have received and progressed on at least 1 prior trastuzumab-containing regimen, but not more than 2, in the metastatic setting.", " Patients may have received prior radiation therapy", " Patients may have received hormonal therapy in the adjuvant or metastatic setting", " 18 years of age or older", " Life expectancy of greater than 6 months", " Normal organ and marrow function as defined in the protocol", " Left ventricular ejection fraction (LVEF) greater than or equal to the institutional lower limit of normal", "Exclusion Criteria:", " Treatment with any investigational drug within 4 weeks", " Long-term treatment, over 3 months, with a systemic steroid or another immunosuppressive agent", " Other malignancies within the past 3 years, except for adequately treated carcinoma of teh cervix or basal-or squamous-cell carcinoma of the skin", " Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001", " An active, bleeding diathesis or an oral anti-vitamin K medication", " Prior treatment with an mTOR inhibitor", " History of non-compliance with medical regimens", " Unwillingness or inability to comply with the protocol", " Major surgery within 2 weeks before study entry", " Patients with active brain metastases or leptomeningeal carcinomatosis", " Patients who have experienced grade 1 or grade 2 hypersensitivity reactions to prior trastuzumab therapy are eligible ONLY IF these reactions did not prevent further administration", " Severe and/or uncontrolled intercurrent medical condition, psychiatric illness or a social situation that could limit their ability to comply with the study requirements.", " Pregnant or breast-feeding women", " HIV positive patients", " Known hypersensitivity to RAD001 (everolimus) or other rapamycins" ]

[ "Outcome Measurement: ", " Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants", " PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.", " Time frame: Baseline up to approximately 34 months", "Results 1: ", " Arm/Group Title: Placebo Plus Nab-Paclitaxel", " Arm/Group Description: Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 451", " Median (95% Confidence Interval)", " Unit of Measure: Months 5.49 (5.32 to 5.59)", "Results 2: ", " Arm/Group Title: Atezolizumab Plus Nab-Paclitaxel", " Arm/Group Description: Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.", " Overall Number of Participants Analyzed: 451", " Median (95% Confidence Interval)", " Unit of Measure: Months 7.16 (5.59 to 7.46)" ]

[ "Outcome Measurement: ", " Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months", " PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.", " Time frame: From the date of randomization to 6-months on study", "Results 1: ", " Arm/Group Title: Ixabepilone 16 mg/m^2", " Arm/Group Description: ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest", " Overall Number of Participants Analyzed: 85", " Measure Type: Number", " Unit of Measure: Percentage of Participants 28.6 (18.9 to 38.9)", "Results 2: ", " Arm/Group Title: Ixabepilone 40 mg/m^2", " Arm/Group Description: ixabepilone 40 mg/m^2 every 3 weeks", " Overall Number of Participants Analyzed: 91", " Measure Type: Number", " Unit of Measure: Percentage of Participants 42.7 (31.5 to 53.5)" ]

[ "Adverse Events 1:", " Total: 8/30 (26.67%)", " Heart Failure 1/30 (3.33%)", " Vertigo 1/30 (3.33%)", " Small intestinal obstruction 1/30 (3.33%)", " Fever 1/30 (3.33%)", " Aspartate aminotransferase increased 1/30 (3.33%)", " Alanine aminotransferase increased 1/30 (3.33%)", " Back Pain 1/30 (3.33%)", " Pleural effusion 1/30 (3.33%)", " Rash maculo-papular 1/30 (3.33%)", " Hypotension 1/30 (3.33%)" ]

[ "Adverse Events 1:", " Total: 2/3 (66.67%)", " Febrile neutropenia 1/3 (33.33%)", " Atrial flutter 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Cardiac failure 0/3 (0.00%)", " Sinus bradycardia 1/3 (33.33%)", " Supraventricular tachycardia 0/3 (0.00%)", " Abdominal pain upper 0/3 (0.00%)", " Dysphagia 0/3 (0.00%)", " Intestinal mass 0/3 (0.00%)", " Pancreatitis acute 0/3 (0.00%)", " Small intestinal obstruction 0/3 (0.00%)", "Adverse Events 2:", " Total: 0/3 (0.00%)", " Febrile neutropenia 0/3 (0.00%)", " Atrial flutter 0/3 (0.00%)", " Atrial fibrillation 0/3 (0.00%)", " Cardiac failure 0/3 (0.00%)", " Sinus bradycardia 0/3 (0.00%)", " Supraventricular tachycardia 0/3 (0.00%)", " Abdominal pain upper 0/3 (0.00%)", " Dysphagia 0/3 (0.00%)", " Intestinal mass 0/3 (0.00%)", " Pancreatitis acute 0/3 (0.00%)", " Small intestinal obstruction 0/3 (0.00%)" ]

[ "INTERVENTION 1: ", " Cabozantinib", " Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity." ]

[ "INTERVENTION 1: ", " Phase I: Cyclophosphamide, Doxil, Trastuzumab", " Patients receive oral cyclophosphamide once daily on days 1-28 and pegylated doxorubicin HCl liposome IV over 90 minutes on day 1. Treatment repeats every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Some patients with HER2/neu 3+ disease may also receive trastuzumab IV over 30-90 minutes weekly or every 3 weeks at the discretion of the treating physician.", " pegylated liposomal doxorubicin hydrochloride: Given IV", " cyclophosphamide: Given orally", " trastuzumab: Given IV" ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast", " Evidence of metastatic involvement (stage IV disease)", " Patients must have measurable disease", " At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)", " Treated brain metastases (surgery or radiation therapy) allowed if clinically stable", " Patients with leptomeningeal disease are ineligible", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Eastern Cooperative Oncology Group (ECOG) performance status 0-2", " Male or female", " Menopausal status not specified", " Absolute neutrophil count (ANC) 1,500/mm^3", " Platelet count 100,000/mm^3", " Creatinine clearance > 50 mL/min", " Fertile patients must use effective contraception", " No history of another severe and/or life-threatening medical disease", " No other active primary malignancy", " Not pregnant or nursing", " Negative pregnancy test", " Patients with asymptomatic HIV infection are eligible", " Liver dysfunction score 9", " No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)", " No active gastrointestinal malabsorption illness", " No clinically significant cardiac disease, including the following:", " Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months", " No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency", " No history of uncontrolled seizures or central nervous system disorders", " No significant history of noncompliance to medical regimens", " No clinically significant psychiatric disability that would preclude study compliance", " PRIOR CONCURRENT THERAPY:", " No previous capecitabine", " Up to 3 prior cytotoxic regimens allowed for metastatic disease", " Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)", " No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy", " No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy", " No other concurrent investigational drugs", " No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)", " Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed", " At least 4 weeks since prior sorivudine or brivudine", " Concurrent use of bisphosphonates allowed if initiated before beginning study therapy", " Concurrent use of megestrol acetate suspension as an appetite stimulant allowed" ]

[ "DISEASE CHARACTERISTICS:", " Histologically or cytologically confirmed primary adenocarcinoma of the breast", " Locally recurrent or metastatic disease", " Must have HER-2-negative breast cancer or, if HER-2-positive, must be unable to receive trastuzumab (Herceptin®) or have previously received trastuzumab in the past", " Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm by conventional techniques or as > 10 mm by spiral CT scan.", " No known CNS disease", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", "Inclusion criteria:", " Postmenopausal status not specified", " ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%", " Life expectancy > 12 weeks", " WBC 3,000/mcL", " Absolute neutrophil count 1,500/mcL", " Platelet count 100,000/mcL", " Total bilirubin normal", " AST and ALT 2.5 times upper limit of normal (ULN)", " Alkaline phosphatase 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)", " Creatinine 1.5 mg/dL", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception", " No other concurrent malignancies within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix", "Exclusion criteria:", " Pre-existing neuropathy grade 1", " Uncontrolled intercurrent illness including, but not limited to, any of the following:", " Ongoing or active infection", " Symptomatic congestive heart failure", " Unstable angina pectoris", " Cardiac arrhythmia", " Serious, non-healing wound, ulcer, or bone fracture", " Psychiatric illness/social situations that would limit compliance with study requirements", " Inadequately controlled hypertension (defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 100 mm Hg on antihypertensive medications)", " History of hypertensive crisis or hypertensive encephalopathy", " New York Heart Association class II-IV congestive heart failure", " History of myocardial infarction or unstable angina within the past 6 months", " History of stroke or transient ischemic attack within the past 6 months", " Significant vascular disease (e.g., aortic aneurysm, aortic dissection)", " Symptomatic peripheral vascular disease", " Evidence of bleeding diathesis or coagulopathy", " Significant traumatic injury within the past 28 days", " History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months", " Proteinuria, as demonstrated by either urine protein:creatinine ratio 1.0 OR urine dipstick for proteinuria 2+", " Patients discovered to have 2+ proteinuria on dipstick urinalysis at baseline must demonstrate 24-hour urine protein 1g", " History of allergy or hypersensitivity to paclitaxel albumin-stabilized nanoparticle formulation, paclitaxel, bevacizumab, carboplatin, albumin, drug product excipients, or chemically similar agents", " PRIOR CONCURRENT THERAPY:", " See Disease Characteristics", " Recovered from all prior therapy", " No prior chemotherapy for locally recurrent or metastatic disease", " Prior neoadjuvant or adjuvant chemotherapy allowed", " More than 1 week since prior core biopsy or other minor surgical procedure, excluding placement of a vascular access device", " More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy", " More than 4 weeks since prior radiotherapy", " More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)", " At least 1 year since prior taxane regimen", " No other concurrent investigational agents", " Concurrent anticoagulation allowed, provided the following criteria are met:", " Stable dose of warfarin or low molecular weight heparin", " INR within desired range (2-3)", " No evidence of active bleeding or coagulopathy", " No concurrent combination antiretroviral therapy for HIV-positive patients", " No other concurrent radiotherapy, chemotherapy, immunotherapy, or antitumor hormonal therapy" ]

[ "Inclusion Criteria:", " Signed written informed consent", " Histologically confirmed primary invasive adenocarcinoma of the breast.", " Clinical stage breast cancer T2-3, N0-3, M0", " Negative HER-2/neu expression as determined by local hospital laboratory using Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using Immunohistochemistry (IHC).", " No prior treatment for primary invasive adenocarcinoma of the breast such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.", " Karnofsky performance status (KPS) of 80 - 100", " The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.", " Baseline MUGA or echocardiogram scans with LVEF of > 50%.", " Normal PTT and either INR or PT < 1.5 x ULN.", " Men or women 18 years of age or older.", " Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.", " Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.", "Exclusion Criteria:", " Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.", " Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.", " Absolute neutrophils count (ANC) < 1500/mm^3", " Total bilirubin > 1.5 times the upper limit of normal (ULN)", " AST or ALT > 2.5 times the upper limit of normal (ULN)", " Platelets < 100,000/mm^3.", " Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or calculated by Cockcroft-Galt method)", " Evidence of metastatic breast cancer following a standard tumor staging work-up", " Evidence of inflammatory breast cancer.", " Evidence of any grade 2 sensory or motor neuropathy.", " Known human immunodeficiency viral (HIV) infection", " Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.", " Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols." ]

[ "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" ]

[ "Inclusion Criteria:", " Female and male patients 18 years of age.", " Histologically confirmed adenocarcinoma of the breast.", " Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-T3, N1-N2, M0). (T1N0M0 lesions are excluded.)", " Patients who have no clearly defined palpable breast mass or axillary lymph nodes but are radiographically measurable are eligible. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. In these patients, radiographic tumor measurements need to be repeated after 3 cycles and prior to surgery.", " Positive HER2 status (overexpression and/or amplification of HER2 in the primary tumor) as defined by: IHC 3+ or fluorescence in situ hybridization (FISH) positive (ratio >2.2) testing. Documentation of the HER2 results must be available at the time of study enrollment.", " An ECOG (Eastern Cooperative Oncology Group) performance score of 2", " Normal bone marrow function as defined by:", " absolute neutrophil count (ANC) >1,500/µL;", " platelets >100,000/µL;", " hemoglobin >10 g/dL.", " Normal hepatic and renal function.", " Left ventricular ejection fraction (LVEF) within the institutional limits of normal, whichever is lower, as measured by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO).", " Life expectancy > 12 weeks.", " Estrogen and progesterone (or estrogen alone) receptor status in the primary tumor known or pending at the time of study enrollment.", " For women of childbearing potential, negative serum pregnancy test within 7 days prior to starting treatment.", " For women of childbearing potential, agreement to use a method of contraception that is acceptable to their physician from time of first signing the informed consent until at least 3 months after the last dose of study drug. 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 agreement to discontinue breast-feeding, if applicable, during study treatment. Men enrolled in the study must also agree to use a method of contraception that is acceptable to their physician during their study participation.", " For patients with previous invasive cancers (including breast cancer) treated with curative intent, completion of chemotherapy or radiation therapy more than 5 years prior to enrollment for this study and no evidence of recurrent disease. Patients may be receiving anti-estrogen hormonal therapy prescribed for previous invasive breast cancer as long as the diagnosis of invasive cancer was made more than 5 years prior to study enrollment. Patients may be using anti-estrogen hormonal therapy at the time of current diagnosis but must discontinue this therapy before beginning study treatment.", " For patients who had, or will have sentinel lymph node and/or axillary dissection prior to initiation of study treatment, completion at least 4 weeks prior to starting study treatment and well-healed wound.", " Ability to understand and willingness to sign a written informed consent document.", "Exclusion Criteria:", " Previous treatment for this breast cancer.", " Evidence of metastatic disease.", " Prior radiation that included 30% of major bone marrow-containing areas.", " Women who are pregnant or breastfeeding.", " Neuropathy (motor or sensory) grade 1 at study entry.", " History of significant cardiac disease or cardiac risk factors or the following:", " uncontrolled arrhythmias", " poorly controlled hypertension (e.g., systolic blood pressure [BP]> 150 mmHg or diastolic BP >100 mmHg) in spite of optimal medical management", " angina pectoris requiring antianginal medication or unstable angina within the previous 6 months", " history of documented congestive heart failure (CHF)", " any documented myocardial infarction within the previous 6 months", " clinically significant valvular heart disease", " current use of medications (e.g., digitalis, beta-blockers, calcium channel-blockers) that alter cardiac conduction, if these medications are administered for the management of cardiac arrhythmia, angina, or CHF. If these medications are administered for other reasons (e.g., hypertension), the patient may be eligible.", " patients with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG unless ECHO or MUGA scan within the last 3 months demonstrates that the LVEF is institutional lower limit of normal.", " Symptomatic intrinsic lung disease.", " Active malignancy, other than superficial basal cell carcinoma, superficial squamous (skin) cell carcinoma, carcinoma in situ, or non-invasive breast cancer, within the past 5 years.", " Uncontrolled intercurrent illness including (but not limited to) ongoing or active infection >grade 2.", " Mental condition or psychiatric disorder rendering the subject unable to understand the nature, scope, and possible consequences of the study or that would limit compliance with study requirements.", " Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving a reasonable suspicion of a disease or condition that contraindicates the use of a study agent or that may affect the interpretation of the results or renders the subjects at high risk from treatment complications.", " Chronic use of CYP3A4 inhibitors and use of the following strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, and voriconazole. Use of these agents must be discontinued at least 72 hours prior to initiation of study treatment.", " Received chemotherapy for any indication within the 5 years preceding study enrollment.", " Prior treatment with trastuzumab or any other anti-HER2 agent for any indication.", " Concurrent treatment with any other anti-cancer therapy.", " Concurrent radiation therapy during neoadjuvant study treatment.", " Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment must be stopped prior to study enrollment.", " Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention of breast cancer. These agents must be discontinued prior to study enrollment.", " Participation within the previous 30 days in a study with an experimental drug.", " Known or suspected allergy to Cremophor EL (polyoxyethylated castor oil), a drug formulated in Cremophor EL such as paclitaxel, or any other agent given in the course of this trial.", " Inability or unwillingness to comply with study procedures including those for follow-up." ]

[ "DISEASE CHARACTERISTICS:", " Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis", " Stage II with at least 10 positive axillary nodes OR", " Stage IIIA or IIIB", " No histologically proven bone marrow metastasis", " No CNS metastasis", " Hormone receptor status:", " Hormone receptor status known", " PATIENT CHARACTERISTICS:", " Age:", " Physiological age 60 or under", " Menopausal status:", " Not specified", "Performance status:", " Karnofsky 80-100%", " Life expectancy:", " See Disease Characteristics", " Hematopoietic:", " Neutrophil count at least 1,500/mm^3", " Platelet count at least 100,000/mm^3", " Hepatic:", " Bilirubin no greater than 1.5 mg/dL", " SGOT or SGPT no greater than 2 times upper limit of normal", " Hepatitis B antigen negative", " Renal:", " Creatinine no greater than 1.2 mg/dL", " Creatinine clearance at least 70 mL/min", " No prior hemorrhagic cystitis", " Cardiovascular:", " Ejection fraction at least 55% by MUGA", " No prior significant valvular heart disease or arrhythmia", " Pulmonary:", " FEV_1 at least 60% of predicted", " pO_2 at least 85 mm Hg on room air", " pCO_2 at least 43 mm Hg on room air", " DLCO at least 60% lower limit of predicted", " Other:", " No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix", " No CNS dysfunction that would preclude compliance", " HIV negative", " No sensitivity to E. coli-derived products", " Not pregnant", " Fertile patients must use effective contraception", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " Not specified", " Chemotherapy:", " At least 4 weeks since prior chemotherapy", " No prior doxorubicin of total dose exceeding 240 mg/m^2", " No prior paclitaxel of total dose of at least 750 mg/m^2", " No more than 12 months since prior conventional-dose adjuvant chemotherapy", " Endocrine therapy:", " At least 4 weeks since prior hormonal therapy", " Radiotherapy:", " At least 4 weeks since prior radiotherapy", " No prior radiation to the left chest wall", " Surgery:", "Not specified" ]

[ "INTERVENTION 1: ", " Cohort A: Triple-negative Breast Cancer Patients", " Patients with triple-negative breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route.", "INTERVENTION 2: ", " Cohort B: ER/PR Positive/HER2-negative Breast Cancer Patients", " Patients with hormone receptor positive (ER and/or PR positive), HER negative breast cancer breast cancer who do not have a pathological complete response following neoadjuvant therapy and surgery will receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days for 6 cycles via the intravenous (IV) route." ]

[ "INTERVENTION 1: ", " Laser Therapy Alone", " therapist administered laser treatment", " laser: therapist administered laser", "INTERVENTION 2: ", " Mld Alone", " therapist administered manual lymphatic drainage", " manual lymphatic drainage: therapist administered massage therapy" ]

[ "INTERVENTION 1: ", " Breast Cancer Patients", " Tomosynthesis Breast Scanning is done and breast CT Scanning is done." ]

[ "INTERVENTION 1: ", " Pralatrexate", " Study drug 190 mg/m^2 for 2 to 4 weeks." ]

[ "Outcome Measurement: ", " Objective Response (ORR)", " Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).", " Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years.", "Results 1: ", " Arm/Group Title: Fulvestrant 250 mg", " Arm/Group Description: Fulvestrant 250 mg", " Overall Number of Participants Analyzed: 47", " Measure Type: Number", " Unit of Measure: Percentage of patients 8.5 (2.4 to 20.4)", "Results 2: ", " Arm/Group Title: Fulvestrant 250 mg + Loading Dose", " Arm/Group Description: Fulvestrant 250 mg + Loading Dose", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: Percentage of patients 5.9 (1.2 to 16.2)" ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.", " Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization", " Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)", "Results 1: ", " Arm/Group Title: Fulvestrant 250 mg", " Arm/Group Description: Fulvestrant 250 mg", " Overall Number of Participants Analyzed: 45", " Measure Type: Number", " Unit of Measure: percentage of participants 11.1", "Results 2: ", " Arm/Group Title: Fulvestrant 250 mg + Loading Dose", " Arm/Group Description: Fulvestrant 250 mg + Loading Dose", " Overall Number of Participants Analyzed: 51", " Measure Type: Number", " Unit of Measure: percentage of participants 17.6" ]

[ "INTERVENTION 1: ", " FFDM and DBT", " FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration", "INTERVENTION 2: ", " FFDM Only", "FFDM exam only" ]

[ "INTERVENTION 1: ", " Lidocaine Patch", " Lidocaine patch 5% (Lidoderm®, Endo Pharmaceuticals Inc.): 1 patch was applied topically to the affected site(s) for 12 hours each day.", "INTERVENTION 2: ", " Placebo Patch", " Placebo patch: 1 patch was applied topically to the affected site(s) for 12 hours each day." ]

[ "Inclusion Criteria", " Histologically-confirmed HER2-positive (IHC 3+ or fluorescence in situ hybridization (FISH) amplified; by clinical assay on either primary or metastatic tumor) adenocarcinoma of the breast with at least one progressive and/or new metastatic brain lesion (>/=5 mm on radiographic imaging) after receipt of intracranial radiation therapy (whole brain radiation therapy, stereotactic radiosurgery, gamma knife, or equivalent). Patients in whom brain metastases (BM) are asymptomatic and detected during routine brain MRI screening per institutional protocols are eligible.", " Prior intracranial radiation therapy (whole brain radiation therapy, stereotactic radiosurgery, gamma knife or equivalent) is allowed but not required.", " Patients with no prior treatment with intracranial Response (ICR) may be included unless ICR is emergently indicated (in consultation with a local therapist, ie neurosurgeon or radiation oncologist)", " Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.", " Life expectancy >12 weeks.", " At least 21 years of age.", " No prior mTOR inhibitors", " Prior navelbine allowed provided navelbine therapy discontinued >/= 12 months from Day 1 of treatment under this protocol.", " Last anti-cancer treatment (including any investigational drug) >/= 2 weeks from initiation of protocol based therapy, provided all adverse events (AEs) (other than alopecia) have resolved to grade 1 at baseline.", " No active serious infection or other comorbid illness which would impair ability to participate in the trial.", " Left ventricular ejection fraction assessment (echocardiogram or multigated acquisition scan (MUGA) scan) performed within 4 weeks prior to study initiation, showing a Left ventricular ejection fraction (LVEF) value lower limit of normal (LLN).", " If patient is on dexamethasone, must be on stable or decreasing dose of dexamethasone for 7 days. If patient is on different glucocorticoid e.g., prednisone, must be converted to dexamethasone prior to enrollment. Refer to dose modification of everolimus for patients taking dexamethasone.", " Interval 4 weeks between open brain biopsy and initiation of protocol-based therapy.", " international normalized ratio (INR) 2.0. Anticoagulation is allowed if target INR 2.0 on a stable dose of warfarin or if patient on a stable dose of Low-molecular-weight (LMW) heparin for >1 weeks at time of enrollment.", " Fasting serum cholesterol 300 mg/dL OR 7.75 mmol/L AND fasting triglycerides 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.", " Patients must have adequate organ function as evidenced by:", " Absolute neutrophil count 1.5/µL", " Platelet count 100,000/µL", " Hg 9 g/dL", " Bilirubin 1.5 x upper limit of normal (ULN)", " aspartate aminotransferase (AST) or Alanine transaminase (ALT) 2.5 x ULN ( 5 x ULN if liver metastases are present)", " Serum creatinine 1.5 x ULN", " Archived, paraffin-embedded tissue block (primary or metastatic) available for genomic studies is required.", " Signed, institutional review board (IRB)-approved written informed consent.", " Exclusion Criteria", " Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus); patients who have received prior treatment with navelbine within prior 12 months.", " patients with a known hypersensitivity to everolimus or other rapamycins (e.g. sirolimus, temsirolimus) or to its excipients.", " Patients requiring treatment with any other systemic glucocorticoid. Note: This restriction regarding choice of glucocorticoid does not apply should patient need <2 week course of glucocorticoid for treatment of non-infectious pneumonitis during study (see section 4.5.2).", " Patients with a known hypersensitivity to vinorelbine or to its excipients.", " Prior allergic reaction to trastuzumab for the treatment of metastatic breast cancer.", " Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.", " Peripheral neuropathy grade 3.", " Evidence of frank hemorrhage or impending herniation on baseline brain imaging. Note: asymptomatic micro-hemorrhage is allowed.", " Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented Cerebrospinal fluid (CSF) cytology. Note: discrete dural metastases are permitted.", " Active cardiac disease including any of the following:", " Angina pectoris that requires the use of anti-anginal medication;", " Ventricular arrhythmias except for benign premature ventricular contractions;", " Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;", " Conduction abnormality requiring a pacemaker;", " Valvular disease with documented compromise in cardiac function;", " Symptomatic pericarditis", " History of cardiac dysfunction including any one of the following:", " Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;", " History of documented congestive heart failure (New York Heart Association functional classification III-IV);", " Documented cardiomyopathy", " Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia), or patients that may require major surgery during the course of the study.", " Patients should not receive immunization with attenuated live vaccines within 1 week of study entry or during study period. Close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus. Examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella, and Typhoid Vaccine Live Oral (TY21a) typhoid vaccines.", " Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.", " Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:", " severely impaired lung function, defined as spirometry and diffusion lung capacity for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% at rest on room air", " uncontrolled diabetes, defined as fasting serum glucose >1.5 x ULN (Note: Optimal glycemic control should be achieved before starting trial therapy)", " active (acute or chronic) or uncontrolled severe infections", " liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).", " Note: A detailed assessment of Hepatitis B/C medical history and risk factors must be done at screening for all patients. Hepatitis B Virus (HBV) DNA and hepatitis C Virus (HCV) RNA polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection.", " A known history of HIV seropositivity.", " Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).", " Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR 2.0).", " Unable or unwilling to discontinue use of prohibited fruit (or its juices) and prohibited medications listed in Appendices II and III for at least 14 days or 5 half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study.", " Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods. Adequate contraception must be used throughout the trial and for 8 weeks after the last dose of study drug, by both sexes. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days prior to everolimus initiation.", " Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment", " Contraindication to gadolinium-enhanced MRI imaging.", " Inability to comply with study and/or follow-up procedures.", " History of noncompliance to medical regimens." ]

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