OncRef

Clinical Trial: NCT00433511

Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-10-01

Study Overview

Brief Summary

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.

Official Title

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

Conditions

Breast Adenocarcinoma

Intervention / Treatment

  • Biological: Bevacizumab
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Drug: Paclitaxel
  • Other: Placebo Administration
  • Other: Quality-of-Life Assessment

Other Study ID Numbers

  • NCI-2009-00561
  • NCI-2009-00561
  • CDR0000528955
  • E5103
  • ECOG-E5103
  • 07-963
  • E5103
  • E5103
  • U10CA180820
  • U10CA021115

Start Date (Actual)

2007-11-02

Primary Completion Date (Actual)

2014-01-07

Study Completion Date (Estimated)

2027-02-20

Enrollment (Actual)

4994

Study Type

Interventional

Phase

Phase 3