drugset / Trial / NCT01303679

1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

NCT01303679

Phase 3 Terminated 117 enrolled ARCAGY/ GINECO GROUP
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

EvaluationDrugModalityDoseRoute
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

Indications