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Title:
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Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 in Patients with HER2 Positive Breast Cancer Previously Treated with Trastuzumab and an Anthracycline and/or a Taxane - IRB# 09-113A
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Treatments:
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Capecitabine, IMC-A12, Lapatinib
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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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IMC-A12, Lapatinib
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Comments:
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Eligibility:
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Histologically confirmed breast cancer, meeting one of the following criteria:Locally advanced disease (i.e., stage IIIB or IIIC [T4 primary tumor] disease) Metastatic disease. Disease progressed after treatment with regimens that included trastuzumab (Herceptin®) in combination with an anthracycline and/or a Taxane. Must have received 1-2 prior chemotherapy regimens in the neoadjuvant, adjuvant, or metastatic setting. One regimen must have included treatment with an anthracycline and/or a Taxane. Prior treatment with trastuzumab required unless there is a contraindication for trastuzumab treatment. HER2-positive disease, defined by any of the following: Validated IHC assay score of 3+ (defined as uniform, intense staining of > 30% of invasive tumor cells), Average HER2 gene copy number > 6, Gene amplified (HER2:D17Z1 ratio > 2.20). Measurable disease according to RECIST criteria. No evidence of active brain metastases, including leptomeningeal involvement. CNS metastasis controlled* by prior surgery and/or radiotherapy is allowed. [Note: *To be considered controlled, there must have been no symptoms for at least 2 months or no evidence of progression prior to study entry AND corticosteroid therapy must have been discontinued]. Hormone receptor status not specified.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center, Northwest Cancer Specialists - Vancouver
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