Conditions: Metastatic Breast Cancer
Keywords: Ribbon 2 Avastin MBC Breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 684
Healthy volunteers: no

Brief 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.

Detailed description:
For all Outcome Measures except Overall Survival and One-year Survival, the Time Frame was from Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years 2 months). For the Outcome Measures Overall Survival and One-year Survival, the Time Frame was from Baseline to the end of the study (up to 6 years, 7 months).

Arms:
arm 1: Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen. arm 2: Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.

Interventions: intervention 1: Bevacizumab intervention 2: Placebo intervention 3: Standard chemotherapy
Intervention descriptions: intervention 1: The dose of bevacizumab was based on a patient's weight at baseline and remained the same throughout the study. intervention 2: None intervention 3: 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.

Protocol document: