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Title:
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A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment - 07-34A
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Treatments:
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-- none --
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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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-- none --
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Comments:
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SWOG (Automatic Specimen Reimbursement): Specimen Tracking System for the following: blood draw. Arm A: dependent on based CTC count a one time payment may occur for follow up of these patients. See specifics in funding memo. Arms B, C1, and C2: A one time payment per patients to offset collection of shipment and serum via SWOG (Automatic Specimen Reimbursement): Specimen Tracking System.
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Eligibility:
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Histologically confirmed breast cancer . Clinical evidence of metastatic disease (stage IV disease). Newly metastatic disease OR progressive metastatic disease while on hormonal therapy. Meets 1 of the following criteria: Measurable disease, Bone-only disease* [Note: *Patients with nonmeasurable disease that does not include bone are not eligible] HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay. HER-2 positivity is defined as IHC 3+ or FISH+ . If IHC is indeterminate (2+), FISH must be performed to classify disease. Planning to undergo first-line chemotherapy for metastatic disease. Patients with brain metastases must have stable disease for > 90 days after completion of prior radiotherapy to the brain. No leptomeningeal disease. Hormone receptor status not specified. Prior/Concurrent Therapy: See Disease Characteristics Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed. Any number of exogenous hormonal therapies for metatstatic disease and/or as adjuvant therapy allowed. At least 1 year since prior adjuvant chemotherapy. At least 2 weeks since prior minor surgery and recovered. At least 4 weeks since prior major surgery and recovered. No prior chemotherapy for metastatic disease. Concurrent hormonal therapy and/or bisphosphonate therapy allowed. Concurrent trastuzumab and/or bevacizumab 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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