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nli4ct_semeval2024

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

[ "INTERVENTION 1: ", " Fulvestrant 250 mg + Tipifarnib 300 mg", " Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity" ]

[ "Adverse Events 1:", " Total: 10/33 (30.30%)", " Constipation 1/33 (3.03%)", " Dysphagia 1/33 (3.03%)", " Ileus 1/33 (3.03%)", " Nausea 1/33 (3.03%)", " Vomiting 1/33 (3.03%)", " Fatigue 1/33 (3.03%)", " Pain 1/33 (3.03%)", " Sepsis 2/33 (6.06%)", " Urinary tract infection 1/33 (3.03%)", " Alanine aminotransferase increased 1/33 (3.03%)", " Aspartate aminotransferase increased 1/33 (3.03%)", " Dehydration 2/33 (6.06%)" ]

[ "Inclusion Criteria:", " Histologically or cytologically confirmed breast carcinoma.", " Early stage breast cancer (stage 1, 2, 3).", " No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.", " 18 years of age or older.", " Final eligibility for a clinical trial is determined by the health professionals conducting the trial.", "Exclusion Criteria:", " Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.", " Major surgery within 28 days of study entry.", " Evidence of central nervous system (CNS) metastases.", " Final eligibility for a clinical trial is determined by the health professionals conducting the trial." ]

[ "Inclusion Criteria:", " Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging", " Surgical patients undergoing lumpectomy, subtotal or total mastectomy", " 18 years of age or greater", " female", " available tissue blocks from diagnostic biopsy", " negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal", " must be willing to forego surgery for minimum of 5 days", " ability and willingness to sign written consent", " if hypertensive, on stable dose of medication at least 30 days", " if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days", " ECOG status < 2 or Karnofsky of 60% or greater", "Exclusion Criteria:", " previous or current malignancy, excluding non-melanomic skin cancer", " evidence of distant metastatic disease", " history of chemotherapy, biologic or radiotherapy with 6 months of biopsy", " usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug", " history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG", " history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications", " active bleeding or a pathological condition that carries a high risk of bleeding", " any swallowing dysfunction", " uncontrolled intercurrent illness", " poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)", " known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.", " uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)", " pregnant or breast feeding women Women must be willing to use birth control throughout study duration.", " current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy", " current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy", " current monoamine oxidase inhibitors treatment" ]

[ "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%)" ]

[ "Outcome Measurement: ", " Percentage of Patients With Pathological Complete Response (pCR) in Patients Who Have Fatty Acid Synthase (FASN) Expression", " pCR is defined as no invasive disease in the breast of axilla at the time of definitive surgery. A patient is considered to have FASN expression if the positivity was >= 15% at the baseline or after 4-7 days of Omeprazole monotherapy. FASN expression is evaluated using immunohistochemistry in core biopsy samples. The percent of patients with FASN expression that have pCR will be calculated with an exact 95% confidence interval.", " Time frame: Up to 6 months", "Results 1: ", " Arm/Group Title: High Dose Omeprazole Treatment", " Arm/Group Description: Patients will be treated with omeprazole 80 mg orally BID beginning 4-7 days prior to chemotherapy and continuing until surgery.", " Overall Number of Participants Analyzed: 29", " Measure Type: Number", " Unit of Measure: percentage of participants 72.4 (52.8 to 87.3)" ]

[ "Adverse Events 1:", " Total: 3/5 (60.00%)", " Febrile neutropenia 3/5 (60.00%)", " Atrial fibrillation 0/5 (0.00%)", " Myocardial Infarction 0/5 (0.00%)", " Blurred Vision 0/5 (0.00%)", " Dysphagia 0/5 (0.00%)", " Fever 0/5 (0.00%)", " General disorders and administration site conditions - Other 0/5 (0.00%)", " Localized edema 0/5 (0.00%)", " Non-cardiac chest pain 0/5 (0.00%)", " Pain 0/5 (0.00%)", " Sepsis 0/5 (0.00%)" ]

[ "Adverse Events 1:", " Total: 17/110 (15.45%)", " Hemoglobin [1]1/110 (0.91%)", " Esophagitis 1/110 (0.91%)", " Dysphagia 1/110 (0.91%)", " Nausea/Vomiting 1/110 (0.91%)", " Nausea 1/110 (0.91%)", " Fever 1/110 (0.91%)", " Febrile Neutropenia 11/110 (10.00%)", " Infection - Other [2]1/110 (0.91%)", " Infection - Pneumonia 1/110 (0.91%)", " Dyspnea 2/110 (1.82%)", " Hypoxia 1/110 (0.91%)" ]

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

[ "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: ", " FFDM Plus DBT", " Breast Images with FFDM and DBT FFDM Plus DBT: FujiFilm Aspire Cristalle System.", " This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate).", "INTERVENTION 2: ", " Full-Field Digital Mammography (FFDM)", " Breast Images with FFDM alone FFDM: FujiFilm Aspire Cristalle System.", " This endpoint will be evaluated qualitatively. The Pass Criteria require adequate performance in non-cancer cases (recall rate) and in cancer cases (detection rate)." ]

[ "Outcome Measurement: ", " Dose Limiting Toxicity (DLT) of Dose-escalating BYL719 in Combination With T-DM1", " DLTs of BYL719 in combination with T-DM1 will be assessed using National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (except for hyperglycemia). A DLT is described any grade 3 or higher, clinically significant toxicity (excluding alopecia) experienced during the first 21 days following first dose of BYL719 that is determined to be at least possibly related to study medication. Lower grades may also be considered DLTs if they lead to a dose interruption of more than 7 consecutive days of BYL719. In general adverse events (AEs) will be graded according to the following:", " Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE", " Time frame: The 1st 21 days (Cycle 1) of treatment", "Results 1: ", " Arm/Group Title: Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)", " Arm/Group Description: Patients receive 250 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " PI3K inhibitor BYL719: Given PO", " Ado-trastuzumab emtansine: Given IV", " Pharmacological study: Correlative studies", " Laboratory biomarker analysis: Optional correlative studies", " Overall Number of Participants Analyzed: 3", " Measure Type: Count of Participants", " Unit of Measure: Participants Thrombocytopenia: 0 0.0%", "Rash Maculopapular: 0 0.0%", "Results 2: ", " Arm/Group Title: Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)", " Arm/Group Description: Patients receive 300 mg PO daily PI3K inhibitor BYL719 on days 1-21 and 3.6mg/kg IV over 30-90 minutes on day 1 ado-trastuzumab emtansine (T-DM1). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.", " PI3K inhibitor BYL719: Given PO", " Ado-trastuzumab emtansine: Given IV", " Pharmacological study: Correlative studies", " Laboratory biomarker analysis: Optional correlative studies", " Overall Number of Participants Analyzed: 5", " Measure Type: Count of Participants", " Unit of Measure: Participants Thrombocytopenia: 1 20.0%", "Rash Maculopapular: 2 40.0%" ]

[ "Outcome Measurement: ", " Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes", " Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.", " Time frame: 4 months", "Results 1: ", " Arm/Group Title: Ultra-rapid Metabolizers", " Arm/Group Description: Those with the highest transformation of the CYP2D6 genotype to allelic activity", " Overall Number of Participants Analyzed: 5", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Baseline endoxifen concentration: 5 participants", " 8.4 (4.59)", " 4-Month endoxifen concentration: 4 participants", " 15.35 (5.48)", "Results 2: ", " Arm/Group Title: Extensive Metabolizers", " Arm/Group Description: Those with the most normal transformation of the CYP2D6 genotype to allelic activity", " Overall Number of Participants Analyzed: 119", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Baseline endoxifen concentration: 119 participants", " 10.00 (6.00)", " 4-Month endoxifen concentration: 106 participants", " 9.30 (5.03)" ]

[ "Inclusion Criteria:", " Inoperable estrogen receptor positive and HER2 negative breast cancer.", " Postmenopausal status.", " Tumor tissue (archived acceptable) available for biomarker studies. For Phase 2 Part 2 - CCND1 amplification and/or loss of p16 as determined by the central laboratory.", " Acceptable bone marrow, liver and kidney function.", "Exclusion Criteria:", " Prior or concomitant treatment for advanced breast cancer.", " Other major cancer in the past 3 years.", " Important cardiovascular events in the past 6 months." ]

[ "Inclusion Criteria:", " Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy", " The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in 10% of invasive cancer cells by Immunohistochemistry.", " HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing", " No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer", " Female subjects age 18 - 70 years", " ECOG Performance Status of 0-1", " Adequate organ and marrow function as defined below:", " Leukocytes 3,000/uL", " Absolute neutrophil count 1500/uL", " Platelets 100,000/uL", " Total bilirubin 1.5mg/dL", " AST(SGOT)/ALT(SPGT) 2 x institutional upper limit of normal", " Creatinine 1.5mg/dl and/or Creatinine Clearance 60mL/min", " Serum albumin 3.0 g/dL", " Women of child-bearing potential must agree to use adequate contraception", " Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration", " Subjects should have LVEF 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation", " Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation", " Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.", " Subjects must be already enrolled in P.R.O.G.E.C.T observational registry", " Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease", " Subjects with bilateral disease are eligible if they meet other eligibility criteria.", " Neuropathy: No baseline neuropathy grade > 2", "Exclusion Criteria:", " Current or anticipated use of other investigational agents", " Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer", " Subject with metastatic disease", " History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study", " Subjects with inflammatory breast cancer", " Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements", " Subject is pregnant or nursing", " Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).", " Ejection Fraction <50% on ECHO or MUGA", " Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade 2 peripheral vascular disease" ]

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

[ "Adverse Events 1:", " Total: 57/57 (100.00%)", " Dry eyes 13/33 (39.39%)", " Heartburn 9/33 (27.27%)", " Nausea after the CT (before day 7) 57/57 (100.00%)", " Herpetic eruption 0/33 (0.00%)", " Dry skin 15/33 (45.45%)", " Alopecia 57/57 (100.00%)", "Adverse Events 2:", " Total: 23/23 (100.00%)", " Dry eyes 2/11 (18.18%)", " Heartburn 2/11 (18.18%)", " Nausea after the CT (before day 7) 23/23 (100.00%)", " Herpetic eruption 3/11 (27.27%)", " Dry skin 9/11 (81.82%)", " Alopecia 23/23 (100.00%)" ]

[ "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:", " Signed informed consent", " At least 19 years old", " Glomerular filtration rate> 60", " Heterogeneously or extremely dense breasts (BI-RADS category c or d).", "Exclusion Criteria:", " History of iodinated contrast allergy", " Pregnant or lactating as determined by routine standard practice", " Personal history of breast cancer", " History of prior breast excisional biopsy (Patients with a history of core needle biopsy will not be excluded)", " History of prior breast reduction mammoplasty surgery", " History of prior breast augmentation surgery", " Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study." ]

[ "INTERVENTION 1: ", " Mometasone", " Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.", "INTERVENTION 2: ", " Placebo", " Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A." ]

[ "INTERVENTION 1: ", " Afatinib Monotherapy", " 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.", "INTERVENTION 2: ", " Afatinib and Paclitaxel or Vinorelbine Combination Therapy", " 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" ]

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

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

[ "Inclusion Criteria", " In order to receive eribulin under this protocol, the subjects oncologist must have documented experience treating subjects with eribulin in a prior clinical study. Subjects who meet all of the following criteria will be included in the treatment protocol:", " Recurrent, locally advanced or metastatic breast cancer that has progressed on or after the last anti-cancer therapy.", " Prior treatment with, ineligibility for, or commercial unavailability of each of the following therapies:", " Anthracyclines, taxanes, and capecitabine.", " Ixabepilone in countries where this agent is marketed.", " Trastuzumab for Her-2 positive disease.", " Hormonal therapy in hormone receptor-positive disease.", " All other marketed therapies, eg, gemcitabine or vinorelbine, used for the treatment of advanced breast cancer.", " Eastern Cooperative Oncology Group (ECOG) performance status </= 2.", " Serum creatinine </= 2.0 mg/dL or creatinine clearance >/= 40 mL/min according to Cockcroft and Gault formula.", " Absolute neutrophil count >/= 1.5 x 10^9/L, hemoglobin >/= 10 g/dL (can be corrected by growth factor or transfusion), and platelet count >/= 100 x 10^9/L.", " Total bilirubin </= 1.5 x upper limit of normal (ULN). Alkaline phosphatase (AP), alanine aminotransferase, and aspartate aminotransferase </= 3 x ULN (</= 5 x ULN in case of liver metastases). In case AP is >3 x ULN (in absence of liver metastases) or >5 x ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.", " Are willing and able to comply with all aspects of the treatment protocol.", " Provide written informed consent.", " Females, age >/= 18 years.", " Female subjects of childbearing potential must agree to be abstinent or to use a highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intra-uterine device, or have a vasectomised partner) having started for at least one menstrual cycle prior to starting eribulin and throughout the entire treatment period and for 30 days (longer if appropriate) after the last dose of eribulin. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.", " Exclusion Criteria Subjects who meet any of the following criteria will be excluded from participation in the treatment protocol:", " Eligible for any other eribulin study that is open in the same region.", " Existing anti-cancer therapy-related toxicities of Grade >/= 2, except that alopecia and Grade 2 neuropathy are acceptable.", " History of congestive heart failure with New York Heart Association Classification >II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia.", " Electrocardiogram with QTc interval >/= 500 msec based upon Bazett's formula (QTcB).", " The Investigator believes the subject to be medically unfit to receive eribulin or unsuitable for any other reason.", " Females who are pregnant (positive B-hCG test) or breastfeeding.", " Subject with hypersensitivity to eribulin or any of the excipients.", " Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this treatment protocol. Any signs (eg, radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting the treatment protocol.", " Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the treatment protocol.", " Subjects who are known to be human immunodeficiency virus positive because the neutropenia caused by the eribulin treatment may make such subjects particularly susceptible to infection.", " Subjects with meningeal carcinomatosis.", " Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.", " Subjects who have received any of the following treatments within the specified period before the start of treatment:", " Any investigational drug, chemotherapy, radiation, or biological or targeted therapy within 2 weeks.", " Hormonal therapy within 1 week." ]

[ "Outcome Measurement: ", " Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer", " The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.", " Time frame: At 48 weeks", "Results 1: ", " Arm/Group Title: Everolimus and Exemestane", " Arm/Group Description: Postmenopausal women diagnosed with oestrogen receptor positive locally advanced or metastatic breast cancer will receive everolimus at a dose of 10mg daily p.o. and exemestane 25mg daily p.o.", " Overall Number of Participants Analyzed: 49", " Measure Type: Number", " Unit of Measure: participants Patients with measurable disease at baseline: 39", " Patients with non-measurable disease at baseline: 10", " Best at WK 48 - Complete Response (CR): 0", " Best at WK 48 - Partial Response (PR): 7", " Best at WK 48 - Stable Disease (SD): 18", " Best at WK 48 - Progressive Disease (PD): 15", "Unknown: 1", "Missing: 8" ]

[ "Inclusion Criteria:", " Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).", "Exclusion Criteria:", " Children (<18 years old)", " Pregnant or Lactating women", " Diabetic patients (Type I or II)", " Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM", " Patients who have NOT undergone a standard of care bilateral breast MRI at UC." ]

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

[ "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)" ]

[ "Inclusion Criteria:", " English speaking", " Diagnosis of stage 1-3 histologically confirmed first cancer of the breast", " Reside in a zip code designated as rural by the United States Department of Agriculture Economic Research Service", " Be within the initial 12 months following the end of primary treatment and meet 3 of the following 5 criteria for MetS confirmed via point-of-care testing or documentation in their medical record:", " A large waistline > 35 inches Blood pressure > 130/85; HbA1c of 5.7%-6.4%; Triglyceride levels > 150 mg/dL; HDL cholesterol levels < 50 mg/dL", "Exclusion Criteria:", " Will not exclude participants based on hormone receptivity, one exception is that we will exclude HER2 positive BCS", " Pregnant patients", " Resistant Hypertension", " Steroid-dependent asthma or Chronic obstructive pulmonary disease", " Cirrhosis or hepatic failure", " A major cardiovascular event (e.g., stroke, myocardial infarction) within the previous 90 days", " Chronic kidney disease on renal replacement therapy", " Type one or two diabetes", " Stage 4 cancer; those with a secondary cancer (except for nonmelanomatous skin cancers and carcinoma of the cervix in situ)", " Taking weight loss medications", " Current involvement in a behavioral program", " Neuropsychiatric disorder or dementia" ]

[ "Inclusion Criteria:", " Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1", " Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable", " HER2-positive breast cancer", " Known hormone receptor status of the primary tumor", "Adequately excised: participants must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy", " Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): eligible participants must have either:", " Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory", " Participants with synchronous bilateral invasive disease are eligible only if both lesions are HER2-positive", " No more than 9 weeks (63 days) may elapse between definitive breast surgery (or the last surgery if additional resection required for breast cancer) and randomization", " Baseline left ventricular ejection fraction (LVEF) >/=55% measured by echocardiogram (ECHO; preferred) or multiple-gated acquisition (MUGA) scans", " Documentation on hepatitis B virus (HBV) and hepatitis C virus (HCV) serology is required", " Female participants of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception. For male participants with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment", "Exclusion Criteria:", " History of any prior (ipsilateral and/or contralateral) invasive breast carcinoma", " History of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin", " Any clinical T4 tumor as defined by tumor-node-metastasis classification in UICC/AJCC 7th edition, including inflammatory breast cancer", " For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (for example, neoadjuvant or adjuvant), including but not limited to, chemotherapy, anti-HER2 therapy (for example, trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, OR anti-cancer radiation therapy (RT) (intra-operative radiotherapy as a boost at the time of primary surgery is acceptable)", " Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any malignancy", " History of DCIS and/or lobular CIS (LCIS) that was treated with any form of systemic chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed. Participants who had their DCIS/LCIS treated with surgery only and/or contralateral DCIS treated with radiation are allowed to enter the study", " Participants with contraindication to RT while adjuvant RT is clinically indicated", " Concurrent anti-cancer treatment in another investigational trial", " Cardiopulmonary dysfunction as defined by protocol: angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease, significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia, myocardial infarction within 12 months prior to randomization, uncontrolled hypertension, evidence of transmural infarction on electrocardiogram (ECG), requirement for oxygen therapy", " Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV", " Any known active liver disease. For participants who are known carriers of HBV/HCV, active hepatitis B/C infection must be ruled out per local guidelines", " Inadequate hematologic, renal or liver function", " Pregnant or lactating women", " Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol", " Chronic immunosuppressive therapies, including systemic corticosteroids" ]

[ "Inclusion Criteria:", " female", " subject is 25-100 years of age", " subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy", " subject is able to provide informed consent", "Exclusion Criteria:", " subject is pregnant", " subject is actively lactating or discontinued breastfeeding less than 2 months ago", " subject has breast implants", " subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study", " subject has contraindications for core biopsy and other invasive procedures", " subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus", " subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months", " subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging" ]

[ "INTERVENTION 1: ", " Health Tracking (Control)", " Participants assigned to the health-tracking condition received usual care and did not attend any meetings.", "INTERVENTION 2: ", " Peer Support", " The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems." ]

[ "INTERVENTION 1: ", " Exemestane (Exemestane Alone)", " oral dose exemestane taken with food (25 mg tablet once daily)", "INTERVENTION 2: ", " Combination (Exemestane + Celecoxib)", " oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)" ]

[ "Adverse Events 1:", " Total: 1/41 (2.44%)", " Infection 1/41 (2.44%)", " Creatinine 1/41 (2.44%)", " Hypokalemia 1/41 (2.44%)", " Bicarbonate 1/41 (2.44%)", " SGOT 1/41 (2.44%)", " Alkaline Phosphatase value 1/41 (2.44%)", " Hyperbilirubineamia 1/41 (2.44%)", " Hypoalbuminemia 1/41 (2.44%)", " Leukocytes 1/41 (2.44%)", " Hemoglobin 1/41 (2.44%)", " Neutrophils 1/41 (2.44%)", " INR 1/41 (2.44%)", " PTT 1/41 (2.44%)", "Adverse Events 2:", " " ]

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

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

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

[ "Adverse Events 1:", " Total: 6/22 (27.27%)", " Thrombocytopenia 1/22 (4.55%)", " leucocytopenia 1/22 (4.55%)", " neutropenia 1/22 (4.55%)", " papilledema 1/22 (4.55%)", " Nausea 1/22 (4.55%)", " hyperglycemia 1/22 (4.55%)" ]

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

[ "Adverse Events 1:", " Total: 23/78 (29.49%)", " Febrile neutropenia * 4/78 (5.13%)", " Neutropenia * 1/78 (1.28%)", " Thrombocytopenia * 0/78 (0.00%)", " Acute coronary syndrome * 1/78 (1.28%)", " Cardiac failure congestive * 1/78 (1.28%)", " Myocardial infarction * 1/78 (1.28%)", " Cardiomyopathy * 0/78 (0.00%)", " Abdominal pain * 1/78 (1.28%)", " Diarrhoea * 1/78 (1.28%)", " Upper gastrointestinal haemorrhage * 1/78 (1.28%)", "Adverse Events 2:", " Total: 24/75 (32.00%)", " Febrile neutropenia * 8/75 (10.67%)", " Neutropenia * 3/75 (4.00%)", " Thrombocytopenia * 2/75 (2.67%)", " Acute coronary syndrome * 0/75 (0.00%)", " Cardiac failure congestive * 2/75 (2.67%)", " Myocardial infarction * 0/75 (0.00%)", " Cardiomyopathy * 1/75 (1.33%)", " Abdominal pain * 0/75 (0.00%)", " Diarrhoea * 1/75 (1.33%)", " Upper gastrointestinal haemorrhage * 0/75 (0.00%)" ]

[ "Adverse Events 1:", " Total: 17", " Anaemia 2/52 (3.85%)", " Febrile neutropenia 4/52 (7.69%)", " Pancytopenia 1/52 (1.92%)", " Thrombocytopenia 0/52 (0.00%)", " Abdominal pain 1/52 (1.92%)", " Constipation 1/52 (1.92%)", " Pyrexia 2/52 (3.85%)", " Hepatic failure 1/52 (1.92%)", " Hyperbilirubinaemia 1/52 (1.92%)", " Device related infection 1/52 (1.92%)", " Pneumonia 2/52 (3.85%)", " Sepsis 1/52 (1.92%)", "Adverse Events 2:", " Total: 7", " Anaemia 0/21 (0.00%)", " Febrile neutropenia 1/21 (4.76%)", " Pancytopenia 0/21 (0.00%)", " Thrombocytopenia 1/21 (4.76%)", " Abdominal pain 0/21 (0.00%)", " Constipation 0/21 (0.00%)", " Pyrexia 1/21 (4.76%)", " Hepatic failure 0/21 (0.00%)", " Hyperbilirubinaemia 0/21 (0.00%)", " Device related infection 0/21 (0.00%)", " Pneumonia 0/21 (0.00%)", " Sepsis 0/21 (0.00%)" ]

[ "INTERVENTION 1: ", " Five Days of Mammosite Therapy", "[Not Specified]" ]

[ "INTERVENTION 1: ", " Bevacizumab Plus Paclitaxel", " Bevacizumab 10 mg/kg intravenous (i.v.), days 1 and 15, every 4 weeks, Paclitaxel 90 mg/m2, days 1, 8 and 15, every 4 weeks", "INTERVENTION 2: ", " Bevacizumab Plus Capecitabine", " Bevacizumab 15 mg/kg i.v., day 1, every 3 weeks, Capecitabine 1000 mg/m² twice-daily, days 1-14, every 3 weeks" ]

[ "Adverse Events 1:", " Total: 267/744 (35.89%)", " Neutropenia *2/744 (0.27%)", " Anaemia *1/744 (0.13%)", " Leukopenia *1/744 (0.13%)", " Thrombocytopenia *1/744 (0.13%)", " Thrombotic thrombocytopenic purpura *1/744 (0.13%)", " Atrial flutter *1/744 (0.13%)", " Cardiac arrest *1/744 (0.13%)", " Myocardial ischaemia *1/744 (0.13%)", " Arrhythmia *0/744 (0.00%)", " Cardiac failure congestive *0/744 (0.00%)", "Adverse Events 2:", " Total: 67/736 (9.10%)", " Neutropenia *1/736 (0.14%)", " Anaemia *0/736 (0.00%)", " Leukopenia *0/736 (0.00%)", " Thrombocytopenia *0/736 (0.00%)", " Thrombotic thrombocytopenic purpura *0/736 (0.00%)", " Atrial flutter *0/736 (0.00%)", " Cardiac arrest *0/736 (0.00%)", " Myocardial ischaemia *0/736 (0.00%)", " Arrhythmia *2/736 (0.27%)", " Cardiac failure congestive *1/736 (0.14%)" ]

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

[ "INTERVENTION 1: ", " 3D HI and SHI of UCA", " Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)", " 3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)" ]

[ "INTERVENTION 1: ", " MAESTRO", "Baseline" ]

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

[ "Inclusion Criteria:", " Written informed consent.", " Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days.", " Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinomas in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.", " Positive axillary lymph nodes defined as at least 1 out of 10 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: TNM pathologic stage N1a, TNM pathologic stage N2a, TNM pathologic stage N3a.", " Status of hormone receptors in primary tumour. Results must be available before the end of adjuvant chemotherapy.", " Patients must not present evidence of metastatic disease. Status of HER2 in primary tumour, known before randomization. Patients with immune histochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescence in situ hybridization (FISH) is mandatory and result must be negative.", " Age >= 18 and <= 70 years old.", " Performance status (Karnofsky index) >= 80.", " Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).", " Laboratory results (within 14 days prior to randomization):", " Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100 x 10^9/l; hemoglobin >= 10 mg/dl;", " Hepatic function: total bilirubin <= 1 upper normal limit (UNL); serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible;", " Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min;", " Pharmacogenetics: one blood sample is needed for single nucleotide polymorphism (SNP) assessment.", " Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests: as clinically indicated.", " Patients able to comply with treatment and study follow-up.", " Negative pregnancy test done in the 14 prior days to randomization.", "Exclusion Criteria:", " Prior systemic therapy for breast cancer.", " Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.", " Prior radiotherapy for breast cancer.", " Bilateral invasive breast cancer.", " Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments.", " Any T4 or M1 tumour.", " Axillary lymph nodes: patients belonging to the following classifications are excluded: TNM pathologic stage N1b, TNM pathologic stage N1c, TNM pathologic stage N2b, TNM pathologic stage N3b, TNM pathologic stage N3c.", " HER2 positive breast cancer (IHC 3+ or positive FISH result).", " Pre-existing grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria version 2.0 [NCICTC v-2.0]).", " Any other serious medical pathology, such as congestive heart failure; unstable angina; history of myocardial infarction during the previous year; uncontrolled hypertension or high risk arrhythmias.", " History of neurological or psychiatric disorders, which could preclude the patients from free informed consent.", " Active uncontrolled infection.", " Active peptic ulcer; unstable diabetes mellitus.", " Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.", " Chronic treatment with corticosteroids.", " Contraindications for corticosteroid administration.", " Concomitant treatment with raloxifene, tamoxifen or other selective estrogen receptor modulators (SERMs), either for osteoporosis treatment or for prevention. These treatments must stop before randomisation.", " Concomitant treatment with other investigational products; participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.", " Concomitant treatment with another therapy for cancer.", "Males." ]

[ "Adverse Events 1:", " Total: 3/49 (6.12%)", " Neutrophils/ANC *1/49 (2.04%)", " Leukocytes *1/49 (2.04%)", " Hypocalcemia *1/49 (2.04%)", " Febrile neutropenia *1/49 (2.04%)", " Left Ventricular Systolic Dysfunction *1/49 (2.04%)", " Constipation *1/49 (2.04%)", " Mucositis-oral *1/49 (2.04%)", " Infection-oral thrush *1/49 (2.04%)", " rash *1/49 (2.04%)" ]

[ "Adverse Events 1:", " Total: 3/12 (25.00%)", " Atrial fibrillation 0/12 (0.00%)", " Cardiac ischemia/infarction [1]0/12 (0.00%)", " Congestive Heart Failure [2]0/12 (0.00%)", " Diverticulitis 0/12 (0.00%)", " Cholecystitis 0/12 (0.00%)", " Hyperbilirubinemia 0/12 (0.00%)", " Urosepsis 2/12 (16.67%)", " Brain hemorrhage complicating CNS metastasis 1/12 (8.33%)", " Rash [3]0/12 (0.00%)" ]

[ "Outcome Measurement: ", " Disease-free Survival (DFS)", " Disease-free survival (DFS) for all patients regardless of randomization will be determined by patients' own physicians at the individual study sites during routine follow-up screening. This will occur every three months for the first 24 months after completion of primary therapies and every six months thereafter with clinical exam, and laboratory and radiographic surveillance. The primary objective of the study is disease-free survival (DFS) at 24 months.", " Time frame: Disease-free survival at 24 months", "Results 1: ", " Arm/Group Title: Herceptin + NeuVax Vaccine", " Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year; the first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive vaccinations of NeuVax vaccine administered intradermally every 3 weeks for 6 total vaccinations, 30-120 minutes after completion of Herceptin infusion. The NeuVax vaccine series will begin immediately after completion of the third Herceptin infusion, but may be delayed to the fourth or fifth Herceptin infusion with prior approval from the PI. After completion of primary vaccine series, patients will receive NeuVax vaccine booster inoculations to be administered every 6 months x 4 for total treatment duration of 30 months.", " Overall Number of Participants Analyzed: 136", " Measure Type: Number", " Unit of Measure: Percentage of participants who survived 89.8", "Results 2: ", " Arm/Group Title: Herceptin + GM-CSF Only", " Arm/Group Description: Patients randomized to this arm will receive Herceptin every 3 weeks as monotherapy for 1 year. The first Herceptin infusion will be given no sooner than 3 weeks and no later than 12 weeks after completion of standard of care chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk. Patients will receive inoculations of GM-CSF only (250mcg) administered intradermally every 3 weeks for 6 total inoculations, 30-120 minutes after completion of Herceptin infusion. The GM-CSF only inoculation series will begin immediately after completion of the third Herceptin infusion. After completion of six-inoculation primary vaccine series, patients will then receive a total of four GM-CSF only booster inoculations to be administered at 12, 18, 24, and 30 months from the date of the first Herceptin infusion.", " Overall Number of Participants Analyzed: 139", " Measure Type: Number", " Unit of Measure: Percentage of participants who survived 83.8" ]

[ "Outcome Measurement: ", " Percentage of Participants With Disease Free Survival at 5 Years", " Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.", " Time frame: From randomization until relapse or death or up to 5 years", "Results 1: ", " Arm/Group Title: Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)", " Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m IV infusion every 3 weeks for another 4 cycles.", " Overall Number of Participants Analyzed: 1073", " Measure Type: Number", " Unit of Measure: percentage of participants 75.5 (72.8 to 78.2)", "Results 2: ", " Arm/Group Title: AC Followed by Docetaxel + Herceptin (AC→TH)", " Arm/Group Description: Doxorubicin 60 mg/m IV bolus injection in combination with cyclophosphamide 600 mg/m IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.", " Overall Number of Participants Analyzed: 1074", " Measure Type: Number", " Unit of Measure: percentage of participants 83.2 (80.9 to 85.4)" ]

[ "Inclusion Criteria:", " Female, age 18 or older", " Diagnosis of breast cancer", " Intact breast (not surgically absent)", " Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)", " Ability to understand and comply with the requirements of this study", " Ability to give Informed Consent", " For sexually active females, patient agrees to use acceptable method of birth control", "Exclusion Criteria:", " Women who are pregnant or lactating", " Use of concomitant skin care preparations at any of the treated or control portal areas to be observed", " Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis", " Severe renal failure creatinine > 3.0 within 6 months of study registration", " Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo", " Planned relocation which would make follow-up visits impossible during the course of the study", " Collagen vascular disease such as Lupus, or scleroderma" ]

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

[ "Adverse Events 1:", " Total: 16/48 (33.33%)", " Febrile neutropenia grade 3 3/48 (6.25%)", " Neutropenia grade 3 1/48 (2.08%)", " Holocraneal cephalea 1/48 (2.08%)", " Hypersensibility reaction grade 3 2/48 (4.17%)", " Palmoplantar erythrodysesthesia grade 3, stomatitis grade 3 1/48 (2.08%)", " Neutropenia grade 4, fever grade 1, oral mucositis grade 3 1/48 (2.08%)", " Catheter - related infection grade 3 1/48 (2.08%)" ]

[ "Adverse Events 1:", " Total: 19/3761 (0.51%)", " Cardiac ischemia/infarction 3/3761 (0.08%)", " Left ventricular systolic dysfunction 1/3761 (0.03%)", " Restrictive cardiomyopathy 1/3761 (0.03%)", " Supraven.arrhyth. Atrial flutter 1/3761 (0.03%)", " Ventric.arrhyth. Trigeminy 1/3761 (0.03%)", " Hypothyroidism 0/3761 (0.00%)", " Blurred vision 1/3761 (0.03%)", " Nyctalopia 0/3761 (0.00%)", " Ocular - Other 1/3761 (0.03%)", "Adverse Events 2:", " Total: 7/3759 (0.19%)", " Cardiac ischemia/infarction 0/3759 (0.00%)", " Left ventricular systolic dysfunction 0/3759 (0.00%)", " Restrictive cardiomyopathy 0/3759 (0.00%)", " Supraven.arrhyth. Atrial flutter 0/3759 (0.00%)", " Ventric.arrhyth. Trigeminy 0/3759 (0.00%)", " Hypothyroidism 1/3759 (0.03%)", " Blurred vision 0/3759 (0.00%)", " Nyctalopia 1/3759 (0.03%)", " Ocular - Other 0/3759 (0.00%)" ]

[ "Adverse Events 1:", " Total: 29/48 (60.42%)", " Anemia 4/48 (8.33%)", " Febrile neutropenia 7/48 (14.58%)", " Atrial fibrillation 1/48 (2.08%)", " Pericardial effusion 1/48 (2.08%)", " Sinus bradycardia 1/48 (2.08%)", " Nausea 2/48 (4.17%)", " Vomiting 2/48 (4.17%)", " Death NOS 1/48 (2.08%)", " Fatigue 3/48 (6.25%)", " Allergic reaction 1/48 (2.08%)", " Lung infection 1/48 (2.08%)", " Mucosal infection 1/48 (2.08%)" ]

[ "INTERVENTION 1: ", " Arm 1 (Paclitaxel, Carboplatin)", " Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.", " Paclitaxel: Given IV", " Carboplatin: Given IV", " Doxorubicin: Given IV", " Cyclophosphamide: Given IV", "INTERVENTION 2: ", " Arm 2 (Veliparib, Paclitaxel, Carboplatin)", " Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.", " Paclitaxel: Given IV", " Carboplatin: Given IV", " Doxorubicin: Given IV", " Cyclophosphamide: Given IV", " Veliparib: Given PO" ]

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

[ "Inclusion Criteria:", " Participants must have histologically confirmed hormone receptor positive (HR+) HER2 negative stage II (except T2N0) or stage III invasive breast cancer. Evaluation for metastatic disease is not required in the absence of symptoms.", " Men and both pre- and postmenopausal women are eligible.", " Prior Treatment:", " Participants may have received (neo)adjuvant chemotherapy, but must be at least 30 days after last dose, with no more than grade 1 residual toxicity at time of screening.", " Participants may have received adjuvant radiotherapy, but must be at least 30 days after last dose , with no more than grade 1 residual toxicity at the time of screening.", " If most recent therapy was surgery, participants must be at least 30 days out from definitive surgery with no active wound healing complications.", " Participants must have demonstrated ability to tolerate endocrine therapy by prior successful completion of at least 1 month of tamoxifen or aromatase inhibitor (AI) therapy without significant adverse events, and in the opinion of the treating physician any ongoing toxicity does not preclude ability to continue on tamoxifen or AI for at least a projected 2 year continuous duration. Ongoing use of any endocrine therapy, including tamoxifen, letrozole, anastrozole, or exemestane, is allowed. Patients may enroll within 2 years of beginning endocrine therapy, as long as there is a plan for at least 2 more years of adjuvant endocrine therapy.", " ECOG performance status 0-1", " Age 18 years.", " Normal organ and marrow function", " Baseline QTc 480 ms", " The effects of palbociclib on the developing human fetus are unknown. Women who might become pregnant must use adequate contraception", " Ability to understand and the willingness to sign a written informed consent document", "Exclusion Criteria:", " Concurrent therapy with other investigational agents.", " Prior therapy with any CDK4/6 inhibitor.", " History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib.", " Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A isoenzymes are ineligible.", " Current use of drugs that are known to prolong the QT interval", " Subjects with organ allograft requiring immunosuppression.", " 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. Breastfeeding should be discontinued prior to entry onto the study.", " Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.", " No ongoing combination antiretroviral therapy" ]

[ "Adverse Events 1:", " Total: 6/168 (3.57%)", " FEBRILE NEUTROPENIA 3/168 (1.79%)", " ENTERITIS 1/168 (0.60%)", " PERIPHERAL NEUROPATHY 2/168 (1.19%)", " DEPRESSION 1/168 (0.60%)" ]

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

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

[ "INTERVENTION 1: ", " 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." ]

[ "Outcome Measurement: ", " Objective Response Rate (ORR)", " Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.", " Time frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.", "Results 1: ", " Arm/Group Title: D+C and Taxane Naive", " Arm/Group Description: Doxil, Carboplatin and Taxane naive", " Overall Number of Participants Analyzed: 39", " Measure Type: Number", " Unit of Measure: percentage of participants 30.8 (17.0 to 47.6)", "Results 2: ", " Arm/Group Title: D+C and Taxane Pretreated", " Arm/Group Description: Doxil, Carboplatin and Taxane pretreated", " Overall Number of Participants Analyzed: 42", " Measure Type: Number", " Unit of Measure: percentage of participants 31.0 (17.6 to 47.1)" ]

[ "Inclusion Criteria:", " Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy", " The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in 10% of invasive cancer cells by Immunohistochemistry.", " HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing", " No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer", " Female subjects age 18 - 70 years", " ECOG Performance Status of 0-1", " Adequate organ and marrow function as defined below:", " Leukocytes 3,000/uL", " Absolute neutrophil count 1500/uL", " Platelets 100,000/uL", " Total bilirubin 1.5mg/dL", " AST(SGOT)/ALT(SPGT) 2 x institutional upper limit of normal", " Creatinine 1.5mg/dl and/or Creatinine Clearance 60mL/min", " Serum albumin 3.0 g/dL", " Women of child-bearing potential must agree to use adequate contraception", " Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration", " Subjects should have LVEF 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation", " Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation", " Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.", " Subjects must be already enrolled in P.R.O.G.E.C.T observational registry", " Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease", " Subjects with bilateral disease are eligible if they meet other eligibility criteria.", " Neuropathy: No baseline neuropathy grade > 2", "Exclusion Criteria:", " Current or anticipated use of other investigational agents", " Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer", " Subject with metastatic disease", " History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study", " Subjects with inflammatory breast cancer", " Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements", " Subject is pregnant or nursing", " Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).", " Ejection Fraction <50% on ECHO or MUGA", " Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade 2 peripheral vascular disease" ]

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

[ "Outcome Measurement: ", " Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year", " Cardiac events defined as:", " Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to 50% LVEF", " Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.", " Time frame: 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment", "Results 1: ", " Arm/Group Title: Pegylated Liposomal Doxorubicin (PLD) Based Regimen", " Arm/Group Description: PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)", " Overall Number of Participants Analyzed: 120", " Measure Type: Number", " Unit of Measure: Participants 5", "Results 2: ", " Arm/Group Title: Doxorubicin Based Regimen", " Arm/Group Description: doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)", " Overall Number of Participants Analyzed: 59", " Measure Type: Number", " Unit of Measure: Participants 11" ]

[ "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" ]

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

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

[ "Inclusion Criteria:", " The patient has provided written informed consent with HIPAA authorization before participating in the study, as has his/her responsible caregiver, if applicable.", " The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.", " The patient is at least 18 years of age at the time of consent.", " The patient has an ECOG performance status of Grade 0 - 2 [8].", " The patient has a clinical negative node status at the time of study entry.", " If of child bearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.", " The patient is currently not participating in another investigational drug study.", " Melanoma Patients", " The patient has a diagnosis of primary melanoma.", " Breast Cancer Patients", " The patient has a diagnosis of primary breast cancer.", " Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.", "Exclusion Criteria:", " The patient is pregnant or lactating;", " The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0);", " The patient has a known hypersensitivity to Lymphazurin or Patent Bleu V.", " Melanoma Patients", " The patient has a tumor with a Breslow depth less than 0.75mm.;", " Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy;", " Patients diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin;", " Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma;", " Patients who have undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap or skin graft of any type).", " Breast Cancer Patients", " The patient has bilateral primary breast cancers or multiple tumors within their breast;", " Patients that have had prior surgical procedures such as breast implants, reduction mammoplasty or axillary surgery;", " Patients scheduled for bilateral mastectomy for any reason;", " Patients that have had preoperative radiation therapy to the affected breast or axilla" ]

[ "Inclusion Criteria:", " Female, 18-100 years old", " Not pregnant or breastfeeding", " Pre-study radiologic documentation of:", " size 5 cm", " unicentric, unilateral", " suspicious mass or calcification", " BIRADS classification IV", " location of abnormality > 1 cm from skin", " Ductal or Infiltrating Ductal Carcinoma", " Grade I-III on final pathology", " Good general health", " Zubrod Performance Status of 0,1, or 2", " No previous chemotherapy", " No palpable axillary or supraclavicular lymph nodes", " If prior non-breast malignancy, must have > 5 year disease-free survival", "Exclusion Criteria:", " Patient < 18 y/o or > 100 y/o", " Pregnant or breastfeeding", " Male", " Breast implants", " Multicentric disease or bilateral disease", " Lesions > 5 cm in diameter", " Lesions < 1.0 cm from the skin", " Previous prior radiation to the breast", " Need for mastectomy", " Diffuse microcalcifications (as determined by the Investigator)" ]

[ "INTERVENTION 1: ", " Digital Breast Tomosynthesis", " Digital Breast Tomosynthesis + Synthetic Mammography (DBT)", " The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.", " Women selected for further assessment (positive screening exam) was recalled.", " Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis.", "INTERVENTION 2: ", " Digital Mammography", " The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not.", " Women selected for further assessment (positive screening exam) was recalled.", " Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis." ]

[ "INTERVENTION 1: ", " Arm I: Yoga Therapy", " Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.", "INTERVENTION 2: ", " Arm II: Wait-List", " Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes." ]

[ "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: 2/2 (100.00%)", " Febrile neutropenia * 2/2 (100.00%)", " Haemorrhage NOS * 0/2 (0.00%)", " Abdominal pain * 0/2 (0.00%)", " Diarrhea * 0/2 (0.00%)", " Melaena * 0/2 (0.00%)", " Mucositis oral * 0/2 (0.00%)", " Nausea * 0/2 (0.00%)", " Vomiting * 0/2 (0.00%)", " Catheter related infection * 0/2 (0.00%)", " Infection NOS * 0/2 (0.00%)", " Leukopenia * 1/2 (50.00%)", "Adverse Events 2:", " Total: 7/29 (24.14%)", " Febrile neutropenia * 1/29 (3.45%)", " Haemorrhage NOS * 1/29 (3.45%)", " Abdominal pain * 1/29 (3.45%)", " Diarrhea * 2/29 (6.90%)", " Melaena * 1/29 (3.45%)", " Mucositis oral * 1/29 (3.45%)", " Nausea * 1/29 (3.45%)", " Vomiting * 1/29 (3.45%)", " Catheter related infection * 1/29 (3.45%)", " Infection NOS * 2/29 (6.90%)", " Leukopenia * 0/29 (0.00%)" ]

[ "Adverse Events 1:", " Total: 23/120 (19.17%)", " Febrile neutropenia 4/120 (3.33%)", " Leukopenia 2/120 (1.67%)", " Neutropenia 8/120 (6.67%)", " Cardiac tamponade 0/120 (0.00%)", " Ventricular arrhythmia 1/120 (0.83%)", " Ascites 0/120 (0.00%)", " Oesophagitis 0/120 (0.00%)", " Large intestine polyp 0/120 (0.00%)", " Death 1/120 (0.83%)", " Liver injury 1/120 (0.83%)", " Pneumonia 3/120 (2.50%)", "Adverse Events 2:", " Total: 30/122 (24.59%)", " Febrile neutropenia 3/122 (2.46%)", " Leukopenia 3/122 (2.46%)", " Neutropenia 9/122 (7.38%)", " Cardiac tamponade 2/122 (1.64%)", " Ventricular arrhythmia 0/122 (0.00%)", " Ascites 1/122 (0.82%)", " Oesophagitis 1/122 (0.82%)", " Large intestine polyp 0/122 (0.00%)", " Death 1/122 (0.82%)", " Liver injury 0/122 (0.00%)", " Pneumonia 5/122 (4.10%)" ]

[ "Adverse Events 1:", " Total: 47/254 (18.50%)", " Anaemia 1/254 (0.39%)", " Febrile neutropenia 1/254 (0.39%)", " Lymphadenopathy 1/254 (0.39%)", " Acute myocardial infarction 1/254 (0.39%)", " Angina pectoris 0/254 (0.00%)", " Angina unstable 0/254 (0.00%)", " Bundle branch block left 0/254 (0.00%)", " Cardiac failure 4/254 (1.57%)", " Coronary artery disease 0/254 (0.00%)", " Coronary artery stenosis 1/254 (0.39%)", "Adverse Events 2:", " Total: 56/269 (20.82%)", " Anaemia 1/269 (0.37%)", " Febrile neutropenia 0/269 (0.00%)", " Lymphadenopathy 0/269 (0.00%)", " Acute myocardial infarction 0/269 (0.00%)", " Angina pectoris 3/269 (1.12%)", " Angina unstable 1/269 (0.37%)", " Bundle branch block left 1/269 (0.37%)", " Cardiac failure 1/269 (0.37%)", " Coronary artery disease 1/269 (0.37%)", " Coronary artery stenosis 0/269 (0.00%)" ]

[ "Adverse Events 1:", " Total: 59/199 (29.65%)", " Anaemia 7/199 (3.52%)", " Thrombocytopenia 2/199 (1.01%)", " Acute myocardial infarction 0/199 (0.00%)", " Atrial fibrillation 1/199 (0.50%)", " Cardiac arrest 1/199 (0.50%)", " Cardiac failure 1/199 (0.50%)", " Cardiopulmonary failure 1/199 (0.50%)", " Left ventricular failure 1/199 (0.50%)", " Supraventricular tachycardia 0/199 (0.00%)", " Ventricular tachycardia 1/199 (0.50%)", "Adverse Events 2:", " Total: 16/36 (44.44%)", " Anaemia 2/36 (5.56%)", " Thrombocytopenia 1/36 (2.78%)", " Acute myocardial infarction 1/36 (2.78%)", " Atrial fibrillation 0/36 (0.00%)", " Cardiac arrest 0/36 (0.00%)", " Cardiac failure 0/36 (0.00%)", " Cardiopulmonary failure 0/36 (0.00%)", " Left ventricular failure 0/36 (0.00%)", " Supraventricular tachycardia 1/36 (2.78%)", " Ventricular tachycardia 0/36 (0.00%)" ]

[ "Adverse Events 1:", " Total: 6/8 (75.00%)", " Thrombocytopenia 1/8 (12.50%)", " Hypertension 1/8 (12.50%)", " Hepatotoxicity 3/8 (37.50%)", " Pancreatectomy * 1/8 (12.50%)" ]

[ "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." ]

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

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

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

[ "Adverse Events 1:", " Total: 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%)" ]

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

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

[ "DISEASE CHARACTERISTICS:", " Current random fine needle breast aspiration (FNA) evidence of 1 of the following:", " Hyperplasia with atypia", " Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4%", " Hyperplasia without atypia but with a BRCAPRO risk of at least 25%", " Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2", " Hyperplasia without atypia but with a history of contralateral ductal carcinoma in situ or invasive breast cancer", " FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal women", " Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal", " No ovarian cysts felt to be possibly or probably non-physiologic that have not resolved to gynecologist's satisfaction on repeat sonogram", " Must agree to have or have had genetic counseling and genetic testing performed for BRCA1 and BRCA2", " No active cancer (e.g., detectable disease)", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age:", " 18 and over", " Sex:", " Female", " Menopausal status:", " Any", "Performance status:", " Not specified", " Life expectancy:", " At least 12 months", " Hematopoietic:", " Hemoglobin greater than 10 g/dL", " Granulocyte count greater than 1,000/mm^3", " No deficiencies in protein C, protein S, or antithrombin III", " No activated protein C resistance", " Hepatic:", " Albumin greater than 3.0 g/dL", " Bilirubin less than 1.5 mg/dL", " AST less than 100 U/L", " Alkaline phosphatase less than 200 U/L", " Renal:", " Creatinine less than 1.5 mg/dL", " Cardiovascular:", " No history of deep venous thrombosis not related to trauma or pregnancy", " No severe coronary artery disease", " No history of prior stroke", " Other:", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective contraception during and for 3 months after study", " No other active cancer", " No retinal vein thrombosis", " No concurrent severe poorly controlled migraine", " No factor V Leiden mutation carrier", " PRIOR CONCURRENT THERAPY:", " Biologic therapy:", " At least 12 months since prior immunotherapy", " Chemotherapy:", " At least 3 months between completion of prior KUMC phase II difluoromethylornithine (DFMO) study and baseline aspiration", " At least 12 months since prior chemotherapy", " Endocrine therapy:", " Must not have started or stopped hormone replacement therapy or oral contraceptives within 6 months of baseline aspiration", " Must continue all hormone replacement therapy and/or oral contraceptives that were being taken at time of baseline aspiration", " At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy", " Radiotherapy:", " At least 3 months since prior radiotherapy", " Surgery:", " At least 6 months between prior oophorectomy and baseline aspiration", " Other:", " At least 2 weeks since the start of other new medication that would be ingested for 1 or more months" ]

[ "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:", " Women aged > 18 years", " Histologically documents metastatic breast cancer", " HER2 positive using Fluorescence In Situ Hybridization (FISH)", " For phase I, patients who have previously received treatment for their metastatic disease are allowed to participate.", " For the phase II portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral CT scan)", " Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2", " A life expectancy of > 3 months", " Use of effective means of contraception", "Exclusion Criteria:", " For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their metastatic disease. Prior treatment in the adjuvant setting is allowed." ]

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

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

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

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

[ "Outcome Measurement: ", " Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)", " Percentage of patients with AEs.", " Time frame: Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.", "Results 1: ", " Arm/Group Title: Single Arm", " Arm/Group Description: fulvestrant (Faslodex )", " Overall Number of Participants Analyzed: 81", " Measure Type: Number", " Unit of Measure: Percentage of participants Adverse Events(AE): 81.5 (71.3 to 89.3)", " ADR; based on current South Korea label.: 38.3 (27.7 to 49.7)", " Serious AE: 11.1 (5.2 to 20.1)", " Serious ADR: 0 (0 to 4.4)", " Unexpected AE: 71.6 (60.5 to 81.1)", " Unexpected ADR: 24.7 (15.8 to 35.5)" ]

[ "Adverse Events 1:", " Total: 0/3 (0.00%)", " Pericardial effusion 0/3 (0.00%)", " Tachycardia 0/3 (0.00%)", " Nausea 0/3 (0.00%)", " Vomiting 0/3 (0.00%)", " Abdominal pain 0/3 (0.00%)", " Colitis 0/3 (0.00%)", " Diarrhoea 0/3 (0.00%)", " Gastritis 0/3 (0.00%)", " Ileus 0/3 (0.00%)", " Fatigue 0/3 (0.00%)", " Pyrexia 0/3 (0.00%)", " Pain 0/3 (0.00%)", " Hepatic cirrhosis 0/3 (0.00%)", " Cellulitis 0/3 (0.00%)", "Adverse Events 2:", " Total: 22/64 (34.38%)", " Pericardial effusion 1/64 (1.56%)", " Tachycardia 1/64 (1.56%)", " Nausea 2/64 (3.13%)", " Vomiting 2/64 (3.13%)", " Abdominal pain 2/64 (3.13%)", " Colitis 1/64 (1.56%)", " Diarrhoea 1/64 (1.56%)", " Gastritis 1/64 (1.56%)", " Ileus 1/64 (1.56%)", " Fatigue 1/64 (1.56%)", " Pyrexia 1/64 (1.56%)", " Pain 1/64 (1.56%)", " Hepatic cirrhosis 1/64 (1.56%)", " Cellulitis 3/64 (4.69%)" ]

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

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

[ "Inclusion Criteria:", " History of biopsy-proven HER-2-overexpressing breast cancer and radiographic evidence of metastatic disease. The HER-2 status can be determined either by immunohistochemistry (score, 3+) or by fluorescence in situ hybridization.", " History of trastuzumab resistance, defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patient may not have received more than 2 prior trastuzumab-based regimens and one lapatinib-based regimen (either as single agent or in combination with chemotherapy)for metastatic breast cancer. Patients who develop metastatic disease during or after adjuvant or neoadjuvant trastuzumab are eligible.", " Performance status 0-2 (by Eastern Cooperative Oncology Group (ECOG) scale).", " Absolute neutrophil count (ANC) 1500/µl or higher; Platelets 100,000/µl or higher; Hemoglobin 9.0 gm/dL or higher; Serum creatinine 2.0 mg/dL or lower; Total bilirubin 1.5 mg/dL or lower; Serum glutamic pyruvic transaminase (SGPT) up to 3* upper limit of normal; Alkaline phosphatase up to 3* upper limit of normal; Calcium 11.0 mg/dL or lower.", " Age 18 years or older.", " Patients must not be pregnant. A pregnancy test will be obtained if the patient is a woman of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).", " Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.", " Patients must have measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral computed tomography (CT) scan.", " Patients may not be receiving any other investigational agents, and must not have received investigational agents within 15 days of enrollment.", " Left ventricular ejection fraction determined by echocardiogram or multigated acquisition (MUGA) (cardiac scan) must be 50% or higher.", "Exclusion Criteria:", " 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", " Prior treatment with any investigational drug within the preceding 15 days", " Chronic treatment with systemic steroids or another immunosuppressive agent", " Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases, and patients diagnosed with brain mets or leptomeningeal disease (LMD) within 3 months.", " Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.", " A known history of HIV seropositivity", " Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (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 coumadin)", " Patients who have received prior treatment with an mTor inhibitor.", " History of noncompliance to medical regimens.", " Patients unwilling to or unable to comply with the protocol.", " Patients who are receiving any other investigational agents", " Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent." ]

[ "Inclusion Criteria:", " Women with diagnosis of breast malignancy", " Women whom requires left chest wall post-mastectomy radiation with or without bolus", " Age 18 years.", " Performance status ECOG </=3", " Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent.", " Patient must be able to maintain a 30 second breath hold.", " Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)", "Exclusion Criteria:", " 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.", " Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants." ]

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

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

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

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed stage IV or recurrent adenocarcinoma of the breast", " Measurable disease", " Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel", " Stable brain metastases allowed", " Hormone receptor status:", " Not specified", " PATIENT CHARACTERISTICS:", " Age", " 18 and over", " Sex", " Male or female", " Menopausal status", " Not specified", " Performance status", " ECOG (Eastern Cooperative Oncology Group) 0-2 OR", " Karnofsky 60-100%", " Life expectancy", " More than 6 months", " Hematopoietic", " WBC(White Blood Count) at least 3,000/mm^3", " Platelet count at least 100,000/mm^3", " Absolute neutrophil count at least 1,500/mm^3", " Hemoglobin at least 8 g/dL", " Hepatic", " Bilirubin normal", " AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal", " Renal", " Creatinine normal OR", " Creatinine clearance at least 60 mL/min", " No clinically significant proteinuria", " No significant impairment of renal function", " Cardiovascular", " No New York Heart Association class III or IV heart disease", " No symptomatic congestive heart failure", " No unstable angina pectoris", " No cardiac arrhythmia", " No inadequately controlled hypertension", " Other", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective barrier contraception", " No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80", " No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer", " No ongoing or active infection", " No peripheral neuropathy greater than grade 1", " No other concurrent uncontrolled medical condition that would preclude study participation", " No psychiatric illness or social situation that would preclude study compliance", " PRIOR CONCURRENT THERAPY:", " Biologic therapy", " Prior trastuzumab (Herceptin) allowed", " Chemotherapy", " See Disease Characteristics", " No prior chemotherapy for recurrent or metastatic disease", " Prior adjuvant chemotherapy allowed", " Endocrine therapy", " Prior hormonal therapy allowed", " Radiotherapy", " Not specified", " Surgery", " Not specified", " Other", " No other concurrent investigational agents" ]

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

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

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

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

[ "Outcome Measurement: ", " Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) Criteria", " Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.", " Time frame: Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.", "Results 1: ", " Arm/Group Title: Caelyx, Docetaxel, Trastuzumab", " Arm/Group Description: Stage 1: subjects will receive Caelyx one day every 3 weeks in combination with docetaxel one day every 3 weeks and trastuzumab once weekly during 6 cycles. At the end of this stage, based on the number of cardiac events, subjects will proceed to a second stage or restart with a lower dose of Caelyx.", " Stage 2: subjects will be treated with the recommended dose of Caelyx (defined in the first stage) in combination with docetaxel and trastuzumab.", " Overall Number of Participants Analyzed: 26", " Measure Type: Number", " Unit of Measure: Participants Participants who had a complete tumor response: 2", " Participants who had a partial tumor response: 13", " Participants who did not have a tumor response: 11" ]

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

[ "Inclusion Criteria:", " Female, age 18 or older", " Diagnosis of breast cancer", " Intact breast (not surgically absent)", " Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)", " Ability to understand and comply with the requirements of this study", " Ability to give Informed Consent", " For sexually active females, patient agrees to use acceptable method of birth control", "Exclusion Criteria:", " Women who are pregnant or lactating", " Use of concomitant skin care preparations at any of the treated or control portal areas to be observed", " Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis", " Severe renal failure creatinine > 3.0 within 6 months of study registration", " Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo", " Planned relocation which would make follow-up visits impossible during the course of the study", " Collagen vascular disease such as Lupus, or scleroderma" ]

[ "DISEASE CHARACTERISTICS:", " Histologically confirmed adenocarcinoma of the breast", " Bilateral synchronous breast tumors allowed", " Any nodal status or tumor size allowed", " No stage IV disease", " HER2/neu-positive disease", " 3+ by IHC OR FISH-amplified", " Hormone receptor status not specified", " PATIENT CHARACTERISTICS:", " Male or female", " Menopausal status not specified", " ECOG performance status 0-1", " Absolute neutrophil count 1,000/mm³", " Platelet count 100,000/mm³", " Bilirubin 1.1 mg/dL", " SGOT or SGPT 2.5 times upper limit of normal (ULN)", " Not pregnant or nursing", " Negative pregnancy test", " Fertile patients must use effective barrier contraception during and after completion of study therapy", " LVEF 50% by MUGA scan", " No peripheral neuropathy > grade 1", " No active second malignancy within the past 5 years except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix", " No known allergy or hypersensitivity to doxorubicin hydrochloride, cyclophosphamide, paclitaxel, or other drugs formulated in Cremophor EL", " No psychiatric illness or concurrent medical conditions that would preclude study treatment", " No other conditions, including any of the following:", " Unstable angina", " Congestive heart failure", " Myocardial infarction within the past 12 months", " High-risk uncontrolled arrhythmias (e.g., ventricular tachycardia, high-grade AV block, or supraventricular arrhythmias that are not adequately controlled)", " No QT prolongation (> 500 ms)", " No active unresolved infections", " No sensitivity to E. coli derived proteins", " PRIOR CONCURRENT THERAPY:", " Prior hormonal therapy for chemoprevention allowed", " No prior trastuzumab (Herceptin®)", " No prior anthracyclines", " No concurrent hormonal therapy, including hormonal contraception (e.g., birth control pills or ovarian hormonal or replacement therapy)", " No other concurrent chemotherapy, radiotherapy, immunotherapy, or biotherapy for breast cancer", " No concurrent drugs that may prolong the QT" ]

[ "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" ]

[ "INTERVENTION 1: ", " Arm I: Yoga Therapy", " Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.", "INTERVENTION 2: ", " Arm II: Wait-List", " Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes." ]

[ "Outcome Measurement: ", " Duration in Days of Grade 4 Neutropenia in Chemotherapy Cycle 1", " Eligible subjects were randomized in a 1:1 ratio. Subjects were dosed with either the F 627 20 mg/dose PFS or Neulasta® 6 mg/dose as the study drug in each chemotherapy cycle. Subjects remained in their assigned treatment arm throughout the study. Subjects were dosed subcutaneously (SC) 24 to 28 hours after receiving TC chemotherapy (75 mg/m2 docetaxel + 600 mg/m2 cyclophosphamide) on Day 2 of each chemotherapy cycle that the subject underwent (up to 4 cycles). Grade 4 (severe) neutropenia was defined as ANC <0.5 × 109/L within the first 12 days of chemotherapy.", " Time frame: The first of 4, 21-day chemotherapy cycles (average 3 weeks)", "Results 1: ", " Arm/Group Title: F-627", " Arm/Group Description: F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles.", " F-627: single dose pre-filled syringe", " Overall Number of Participants Analyzed: 197", " Mean (Standard Deviation)", " Unit of Measure: days 0.2 (0.51)", "Results 2: ", " Arm/Group Title: Neulasta", " Arm/Group Description: 6 mg fixed dose Neulasta , administered on Day 2 of each of 4 chemotherapy cycles", " Neulasta: single dose pre-filled syringe", " Overall Number of Participants Analyzed: 196", " Mean (Standard Deviation)", " Unit of Measure: days 0.2 (0.45)" ]

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

[ "Outcome Measurement: ", " Endoxifen Concentrations in Participants Receiving Tamoxifen Citrate Dose of 20 mg or 40 mg Stratified by the Metabolizing CYP2D6 Genotypes", " Measurements of plasma concentrations of the key active metabolite of tamoxifen, endoxifen, were measured at baseline and after 4 months of treatment; The most common CYP2D6 alleles have been grouped by functional activity classifications with descending activity: ultra-rapid (UM), extensive (EM), intermediate (IM) or poor (PM) metabolism. A given patient has two alleles, giving them 10 possible allelic combinations, or diplotypes (UM/UM, UM/EM, EM/EM, etc.). These diplotypes are collapsed into four phenotypes, UM, EM, IM or PM.", " Time frame: 4 months", "Results 1: ", " Arm/Group Title: Ultra-rapid Metabolizers", " Arm/Group Description: Those with the highest transformation of the CYP2D6 genotype to allelic activity", " Overall Number of Participants Analyzed: 5", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Baseline endoxifen concentration: 5 participants", " 8.4 (4.59)", " 4-Month endoxifen concentration: 4 participants", " 15.35 (5.48)", "Results 2: ", " Arm/Group Title: Extensive Metabolizers", " Arm/Group Description: Those with the most normal transformation of the CYP2D6 genotype to allelic activity", " Overall Number of Participants Analyzed: 119", " Mean (Standard Deviation)", " Unit of Measure: ng/mL Baseline endoxifen concentration: 119 participants", " 10.00 (6.00)", " 4-Month endoxifen concentration: 106 participants", " 9.30 (5.03)" ]

[ "Outcome Measurement: ", " Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment", " The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.", " Since there is no independent reviewer, only the investigator response was reported.", " Time frame: up to week 12", "Results 1: ", " Arm/Group Title: Lapatinib + Bevacizumab", " Arm/Group Description: Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)", " Overall Number of Participants Analyzed: 52", " Measure Type: Count of Participants", " Unit of Measure: Participants No disease progression by Week 12: 36 69.2%", " Disease progression or death by Week 12: 16 30.8%" ]

[ "INTERVENTION 1: ", " Dexamethasone + Ondansetron IV", " All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.", " Patients receive dexamethasone IV or orally and ondansetron IV on day 1 (prior to each dose of doxorubicin hydrochloride).", "INTERVENTION 2: ", " Dexamethasone + Palonosetron IV", " All patients receive doxorubicin hydrochloride IV on day 1 and oral cyclophosphamide on days 1-7.", " Patients receive dexamethasone IV or orally and palonosetron IV on day 1 (prior to each dose of doxorubicin hydrochloride)." ]

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

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

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

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

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

[ "Inclusion Criteria:", " HER-2 negative advanced breast cancer with chest wall metastasis confirmed by histology or cytological examination (patients who have received anthracyclines and/or paclitaxel in adjuvant chemotherapy).", " Patients with recurrence or metastasis who have received no more than two lines of chemotherapy.", " If hormone receptor is positive, endocrine therapy must have been performed for the patients with recurrence or metastasis, or the recurrence or metastasis occurred in less than two years of endocrine therapy.", " 18 years old.", " Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.", " A life expectancy of more than 3 months.", " At least one measurable site of disease confirmed by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was required.", " If the target lesions are lymph nodes, the short diameter is required to be less than 1.5cm and the target lesions are not suitable for surgical treatment; target lesions have not been in radiotherapy or recurred in the radiation field.", " Baseline blood routine examination in accordance with the following criteria: neutrophil counts more than 1.5*109/L; platelet counts greater than 100*109/L; hemoglobin greater than 9 g/dL (blood transfusion is allowed to achieve or maintain the index)", " Liver function in accordance with the following criteria: total bilirubin less than 1.5 times the upper limit of normal value; aspartate aminotransferase (AST), alanine aminotransferase (ALT) less than 2.5 times the upper limit of normal value, less than 5 times the upper limit of normal value in patients with liver metastases.", " Renal function in accordance with the following criteria: serum creatinine less than 1.25 times the upper limit of normal value, or the creatinine clearance rate calculated greater than 50 mL/min;", " Women with fertility are willing to take contraceptive measures in the trial: when seven days before the drug delivery of serum or urine pregnancy test negative.", "Exclusion Criteria:", " receiving radiation therapy 28 days before enrolled. Radiotherapy before enrollment to relieve the metastatic bone pain is allowed, but medullary bone radiated should not exceed 30% of the total amount;", " symptomatic central nervous system metastases;", " current or recent (30 days before enrollment) use of another study drug or being involved in another clinical study;", " Other malignant tumors that have occurred within 5 years (except for the cured or well-controlled cervical carcinoma in situ, skin squamous cell carcinoma, or skin basal cell carcinoma);", " With hypertension and the blood pressure cannot be reduced to the normal range through antihypertensive drug treatment (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg).", " With grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval more than or equal to 450 ms for men, more than or equal to 470 ms for female);", " according to the criteria of NYHA, cardiac insufficiency of grade III and IV or left ventricular ejection fraction (LVEF) less than 50% revealed by echocardiography;", " abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 times the ULN), with bleeding tendency or under thrombolysis or anticoagulation therapy;", " within 3 months before enrollment, clinically significant bleeding symptoms occur, or having obvious bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, occult blood + + and above in baseline period, or suffering from vasculitis, et al;", " within 4 months before enrollment receiving major surgery or getting severe traumatic injury, fracture or ulcer;", " having factors that affect the absorption of the oral drugs obviously, such as the inability to swallow, chronic diarrhea and intestinal obstruction, et al;", " urine routine test with urinary protein more than ++, or 24 hour urinary protein more than 1.0 g;", " with symptomatic serous cavity effusion, which needs to be surgically managed (including pleural effusion, ascites, pericardial effusion);", " with other possible conditions that can affect the clinical research or evaluation of the results judged by the researchers." ]

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

[ "Inclusion Criteria:", " Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)", " HER2-positive metastatic or locally advanced breast cancer", " For MBC participants:", " Documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel", " History of disease progression within 3 months prior to study entry", " For LABC participants:", " Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer [AJCC] staging system)", "Exclusion Criteria:", " Significant cardiac disease", " Inadequate bone marrow, liver or renal function", " For MBC participants:", " Participants must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases", " Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.", " For LABC participants:", " Clinically or radiologically detectable metastasis (M1 disease)", " Participants for whom surgery as primary intent procedure is the best option to treat their disease", " Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease" ]

[ "Adverse Events 1:", " Total: 88/291 (30.24%)", " Anemia3/291 (1.03%)", " Febrile Neutropenia11/291 (3.78%)", " Leukopenia1/291 (0.34%)", " Neutropenia7/291 (2.41%)", " Thrombocytopenia2/291 (0.69%)", " Cardiac Arrest1/291 (0.34%)", " Pericardial Effusion1/291 (0.34%)", " Pericarditis1/291 (0.34%)", " Tachycardia2/291 (0.69%)", " Diplopia1/291 (0.34%)", " Macular Hole1/291 (0.34%)", " Abdominal Pain3/291 (1.03%)" ]

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

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

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

[ "INTERVENTION 1: ", " Arm I (Cranial Microcurrent Electrical Stimulation [CES])", " Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.", " energy-based therapy: Given once a day for 18 weeks", "INTERVENTION 2: ", " Arm II (Sham CES)", " Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.", " sham intervention: Given once a day for 18 weeks" ]

[ "INTERVENTION 1: ", " Treatment Gel + Oral Placebo", " 4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.", " oral placebo: Oral placebo taken daily for 4-10 weeks.", " afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks.", "INTERVENTION 2: ", " Placebo Gel + Oral Treatment", " Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).", " tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.", " placebo gel: Placebo gel applied to breasts daily for 4-10 weeks." ]