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Title:
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A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound (Nab)-Paclitaxel or Ixabepilone Combined with Bevacizumab as First or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer - IRB# 09-006A
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Treatments:
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Bevacizumab, Ixabepilone, Nab-paclitaxel, Paclitaxel
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Disease Site:
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Breast
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Disease SubSite:
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Metastatic breast
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Drug Provided:
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Bevacizumab, Ixabepilone, Nab-paclitaxel
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Comments:
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Eligibility:
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Histologically confirmed invasive breast cancer. Stage IIIB or IV (locally recurrent or metastatic) disease not amenable to local therapy. Measurable disease (target lesions), defined as =>1 lesion that can be accurately measured in => 1 dimension (longest diameter to be recorded) as => 2.0 cm with conventional techniques or as => 1 cm with spiral CT scan. No non-measurable lesions, including any of the following: Ascites, Pleural/pericardial effusion, Inflammatory breast disease, Lymphangitis cutis/pulmonitis, Bone lesions, Leptomeningeal disease, Cystic lesions, Abdominal masses not confirmed and followed by imaging techniques, No prior chemotherapy regimen for metastatic or locally advanced breast cancer, HER2/neu status must be known, HER2- positive disease allowed, provided patient received prior trastuzumab (Herceptin®) or lapatinib (documentation of progression on HER2-directed therapy is not required), Hormone receptor status must be known, Estrogen receptor (ER)- and progesterone receptor (PgR)-positive if => 1% cells are positive. No progressing or untreated CNS metastases or leptomeningeal disease. History of resected brain metastases with stable MRI scans for 3 months including within the past 4 weeks allowed. History of gamma-knife radiosurgery or whole-brain radiation with stable MRI scans for 3 months, including within the past 4 weeks allowed.
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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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