CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 4,994 enrolled
Drug / intervention
Bevacizumab +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00433511
NCT00433511Phase 3Active

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

National Cancer Institute (NCI)·interventional·Posted Feb 12, 2007·Updated May 29, 2026

In Brief

A Phase 3 clinical trial evaluating Bevacizumab, Cyclophosphamide, and 5 other interventions for Breast Adenocarcinoma. Active but no longer recruiting, targeting 4,994 participants across 843 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPeru, South Africa, United States

Timeline

Phase 3Active
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2007
Enrollment StartNov 2, 2007
Primary CompletionJan 7, 2014
Study CompletionFeb 20, 2027
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 19.4 years ago

Interventions

Bevacizumabbiological

Given IV

Cyclophosphamidedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV

Placebo Administrationother

Given IV

Quality-of-Life Assessmentother

Ancillary studies (closed as of 5/28/10)