drugset / Trial / NCT00464646
Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer
Phase 2
Completed
105 enrolled
NSABP Foundation Inc
Genentech, Inc. · collabInternational Drug Development Institute · collab
NaSingle-groupOpen-labelTreatment
Summary
The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate: * How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect breast tumors * Side effects from adding bevacizumab to chemotherapy and trastuzumab * Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart * If receiving bevacizumab will have any effect on how patients recover from surgery
Timeline
- Start
- 2007-05
- Primary completion
- 2009-12
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |