drugset / Trial / NCT01303679
1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab. Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.
Timeline
- Start
- 2010-06
- Primary completion
- 2014-06
- Completion
- 2018-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Exemestane | Small molecule | 25 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |