drugset / Trial / NCT00887536
A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer
Phase 3
Completed
1613 enrolled
NSABP Foundation Inc
Genentech, Inc. · collabUS Oncology Research · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.
Timeline
- Start
- 2009-05
- Primary completion
- 2018-02
- Completion
- 2018-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |