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Title:
E5103 A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamidefollowed by Paclitaxel with Bevacizumab or Placebo in Patients with LymphNode Positive and High Risk Lymph Node Negative Breast Cancer
Protocol Number:
E5103
Phase:
Phase III
Physician:
Antonio Wolff
Purpose:
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.
Eligibility:
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.
Treatment:
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.
Population:
Adult
Last Update
04/17/2014 04:02 AM
 

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