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NCT00433511 · ClinicalTrials.gov record · last posted 2026-08-26

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

StatusActive, Not Recruiting
PhasePhase 3
Started2007-11-02
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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.

Protocol amendment history 1 change detected by DataLookout

2026-05-13
minor
Completion pushed: 2026-02-22 → 2027-02-20
Trial Details
NCT Number NCT00433511
Lead Sponsor National Cancer Institute (NCI)
Collaborators: Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, North Central Cancer Treatment Group
Conditions Breast Adenocarcinoma
Enrollment 4,994 participants
Start Date 2007-11-02
Primary Completion 2014-01-07 (estimated)
Study Completion 2027-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-08-26