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

Study Status

Open to Enrollment

Study Description

This clinical trial is studying doxorubicin, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer.

Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor.

Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether doxorubicin, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab in treating breast cancer.  There are 3 study arms:

Arm I: Active Comparator

Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.

Interventions:
  • Drug: AC regimen
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: paclitaxel
  • Other: placebo

Arm II: Experimental

Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.
Interventions:
  • Biological: bevacizumab
  • Drug: AC regimen
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: paclitaxel

Arm III: Experimental

Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab as in arm II. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm I and bevacizumab as in arm II. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive open-label bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses.
Interventions:
  • Biological: bevacizumab
  • Drug: AC regimen
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: paclitaxel

Disease Status and/or Stage

Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer

Sponsor

Eastern Cooperative Oncology Group; National Cancer Institute

Key Eligibility

  • Male or female, age 18 and over
  • Diagnosed with breast cancer
  • Significant risk of distant recurrence based on
    • Axillary lymph node positive disease
    • Axillary lymph node negative disease
  • Has undergone definitive breast surgery within 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
  • Planned postlumpectomy radition 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-masectomy radiation therapy required for patients with a primary tumor of ≥ 5 cm or involvement of ≥ 4 lymph nodes
  • Additional eligibility requirements discussed when you contact the study team

Principal Investigator

Linda Vahdat, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (212) 746-9498
roh2026@med.cornell.edu

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