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Title:
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A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptor-Positive Advanced Breast Cancer - IRB# 08-126A
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Treatments:
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Bevacizumab, Goserelin, Letrozole, Leuprolide, Tamoxifen
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Disease Site:
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Breast
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Disease SubSite:
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Advanced Breast Cancer HR+
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Drug Provided:
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Bevacizumab, Letrozole
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Comments:
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Eligibility:
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Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting. Stage IIIB disease not amenable to local therapy or stage IV disease. Must have measurable or nonmeasurable disease by RECIST criteria, with radiologic scans (CT scan of the chest/abdomen). Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as =>2.0 cm with conventional techniques or as => 1.0 cm with spiral CT scan. Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly nonmeasurable lesions, including any of the following: Bone lesions, Leptomeningeal disease, Ascites, Pleural/pericardial effusion, Inflammatory breast disease, Abdominal masses that are not confirmed and followed by imaging techniques, Cystic lesions. Baseline bone scans required for all patients for determination of metastatic bone disease. CT scan with bone windows required only for patients with bone metastases as the only site of disease. No known CNS metastases or leptomeningeal disease (screening with brain imaging is not required for asymptomatic patients). Hormone receptor status: tumors (from either primary or metastatic sites) must express estrogen receptor (ER) and/or progesterone receptor (PgR) in => 1% of cells.
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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
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