At a glance
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A Phase III, Multicenter, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy Regimens in Subjects With Previously Treated Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Bevacizumab, Placebo, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 684 participants.
Detailed 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.
Study Details
Timeline
Interventions
The dose of bevacizumab was based on a patient's weight at baseline and remained the same throughout the study.
Patients received one of the following four standard chemotherapies for metastatic breast cancer. 1. Taxane - Paclitaxel (Taxol) 90 mg/m\^2 IV every week for 3 weeks followed by 1 week of rest; paclitaxel (Taxol) 175 mg/m\^2 IV every 3 weeks, or paclitaxel protein-bound particles (Abraxane) 260 mg/m\^2 IV every 3 weeks; or docetaxel (Taxotere) 75-100 mg/m\^2 IV every 3 weeks. 2. Gemcitabine (Gemzar) 1250 mg/m\^2 IV on Days 1 and 8 of each 3-week cycle. 3. Vinorelbine (Navelbine) 30 mg/m\^2 IV every week of each 3-week cycle. 4. Capecitabine (Xeloda) 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week cycle.