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Title:
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CIRG (TRIO) 011/NSABP B-44-I/BO20906: A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab - IRB# 08-41A
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Treatments:
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Bevacizumab, Carboplatin, Dexamethasone, Docetaxel, Trastuzumab
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Disease Site:
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Breast
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Disease SubSite:
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Drug Provided:
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Bevacizumab
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Comments:
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INVESTIGATORS MUST BE REGISTERD TO ENROLL PATEINTS IN THIS TRIAL. Bevacizumab, urine tests, scheduled echocardiograms/MUGA scans, and HER2 test provided.
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Eligibility:
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Life expectancy of at least 10 years, excluding their diagnosis of breast cancer. Women who have had breast reconstruction utilizing tissue expanders must be in agreement with not having expansion performed within 2 weeks before the first dose of bevacizumab, during bevacizumab therapy, and until 6 weeks following the last dose of Bevacizumab. Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab. Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial. Signed and dated IRB/EC-approved consent. ECOG performance status of 0 or 1. The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. (If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+. All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3; By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm; ER negative and PgR negative; Histologic and/or nuclear grade 2 (intermediate) or 3 (high); or Age < 35 years.
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Participating Sites:
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See the approved investigator list below
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