E5103 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
To determine if adding bevacizumab to standard treatment with doxorubicin and cyclophosphamide, followed by paclitaxel will increase how long patients live without a recurrence of breast cancer (also called "disease free survival"). The study will also compare short-term (20-24 weeks) versus long-term (50-54 weeks) bevacizumab therapy.
Women and men with newly diagnosed lymph node positive or high risk lymph node negative breast cancer who also meet the following may be eligible: have a HER2 negative cancer, have had a mastectomy or lumpectomy and evaluation of the lymph nodes, have no evidence of breast cancer after surgery, and do not have a history of significant heart disease.
All patients will receive doxorubicin and cyclophosphade ("AC"), followed by paclitaxel (or Taxol). Patients will be randomized (like the flip of a coin) to receive either bevacizumab or placebo during the first 7 cycles of treatment; neither the patient nor the doctor will know what treatment group the patient is in. After those 7 cycles, the patient and the doctor will be told whether bevacizumab or placebo was given. After the standard chemotherapy has ended (8 cycles) some patients may receive additional, long-term bevacizumab therapy. All patients will be asked to give a single blood sample and allow access to tissue collected from their surgery for special research tests.
12/08/2013 04:02 AM