drugset / Trial / NCT00281697

A Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With Chemotherapy in Previously Treated Metastatic Breast Cancer (RIBBON 2)

NCT00281697

Phase 3 Completed 684 enrolled Genentech, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This phase III, multicenter, randomized, placebo-controlled, blinded trial is designed to evaluate the efficacy and safety of bevacizumab when combined with standard chemotherapy compared with chemotherapy alone in subjects with previously treated metastatic breast cancer.

Timeline

Start
2006-02
Primary completion
2009-03
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 15 mg/kg Intravenous
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Docetaxel Small molecule 100 mg/m2 Intravenous
Background Gemcitabine Small molecule 1250 mg/m2 Intravenous
Background Paclitaxel Small molecule 90 mg/m2 Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous
Background Paclitaxel Small molecule 260 mg/m2 Intravenous
Background Vinorelbine Small molecule 30 mg/m2 Intravenous

Indications