Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 1, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT00433511). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 4994 participants (ACTUAL). Conditions: Breast Adenocarcinoma. Interventions: BIOLOGICAL: Bevacizumab; DRUG: Cyclophosphamide; DRUG: Doxorubicin Hydrochloride; OTHER: Laboratory Biomarker Analysis; DRUG: Paclitaxel; OTHER: Placebo Administration; OTHER: Quality-of-Life Assessment. Primary outcome measures: Invasive Disease-free Survival (IDFS) Rate at 5 Years , Assessed at 5 years. 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.