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Title:
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A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer - IRB# 08-40A
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Treatments:
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Bevacizumab, Cyclophosphamide, Doxorubicin
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Disease Site:
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Breast
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Disease SubSite:
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Node negative or positive
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Drug Provided:
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Bevacizumab
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Comments:
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Eligibility:
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Histologically confirmed adenocarcinoma of the breast. Significant risk of distant recurrence based on =>1 of the following criteria: At least 1 axillary lymph node positive on routine histologic, examination (must be demonstrated by more than immunohistochemistry alone), Estrogen receptor (ER)-negative tumor=>1 cm , ER+ tumor=> 5 cm regardless of recurrence score, ER+ tumor =>1 cm but <5 cm with a recurrence score =>11, Patients enrolled on ECOG-PACCT-1 clinical trial are eligible, Has undergone definitive breast surgery within the past 29-84 days, including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection, or lumpectomy and sentinel node biopsy.Surgical margins must be histologically free of invasive breast cancer and ductal carcinoma in situ. Resection margins positive for lobular carcinoma in situ allowed. Planned post-lumpectomy radiation therapy required, including any of the following: Whole breast radiation therapy after chemotherapy, Accelerated partial breast radiation therapy after chemotherapy , Accelerated partial breast radiation therapy prior to chemotherapy, Planned post-mastectomy radiation therapy required for patients with a primary tumor of > 5 cm or involvement of =>4 lymph nodes, No HER2/neu positive breast cancer (i.e., 3+ by immunohistochemistry or positive by fluorescent in situ hybridization [FISH]). No clinical evidence of inflammatory disease or fixed axillary nodes (N2) at diagnosis. May have synchronous bilateral breast cancer (diagnosed =<1 month) if the higher TNM stage tumor meets the eligibility criteria for this trial. Hormone receptor status known. Prior/Concurrent Therapy: See Disease Characteristics. More than 28 days since prior major surgery. Nonoperative biopsy not considered major surgery.
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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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