Current Research: Medical Oncology

E5103– Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer

The purpose of this research study is to:

• Determine the disease-free survival of patients with lymph node positive and high risk lymph node negative breast cancer randomized to treatment.
• Compare short-term (20-24 weeks) versus long-term (50-54 weeks) Bevacizumab therapy.
• Find out what overall effects (good and bad) the study treatment has on you and your cancer.

Eligibility

You may be eligible for this trial if:

• You have completed definitive breast surgery including: total mastectomy or breast conservation surgery with axillary dissection and/or sentinel node biopsy at significant risk of distant recurrence
• The margins of your breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ. Patients with resection margins positive for LCIS are eligible.
• The interval between your last surgery for breast cancer (mastectomy, breast conservation surgery, etc) and Day 1 of treatment must be between 28-84 days.
• You must not have any major surgical procedure within 28 days of Day 1 treatment.
• You must not have received prior cytotoxic chemotherapy or hormonal therapy for this breast cancer. Prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed.
• HER2 + (3+ by IHC or FISH+) are NOT ELIGIBLE.
• Patients with synchronous bilateral breast cancer (diagnosed within 1 month) are eligible if the higher TNM stage tumor meets the eligibility criteria for this trial.

Trial Sponsor

• Eastern Cooperative Oncology Group (ECOG)

Project Begin Date

• Sept 2008

Tentative Project End Date

• Dec 2009

Back to Medical Oncology Research

Revised April 14, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .