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

Sponsor
Genentech, Inc.
Study ID
NCT00281697
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    The dose of bevacizumab was based on a patient's weight at baseline and remained the same throughout the study.
  • Placebo — DRUG
  • Standard chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jan 25, 2006
Start date
Feb 28, 2006
Status verified
Jul 2013
Primary completion
Mar 31, 2009
Completion
Sep 30, 2012

Study Design

Enrollment
684 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard chemotherapy + bevacizumab
    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.
  • Placebo Comparator: Standard chemotherapy + placebo
    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.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]

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