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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00281697
First received: January 23, 2006
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
Results First Received: August 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Bevacizumab
Drug: Placebo
Drug: Standard chemotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Standard Chemotherapy + Bevacizumab     Standard Chemotherapy + Placebo  
STARTED     459     225  
COMPLETED     58     28  
NOT COMPLETED     401     197  
> 60 days since last dose of study drug                 4                 4  
Adverse Event                 54                 15  
Death                 8                 3  
Disease progression                 279                 149  
Not specified                 5                 6  
Physician's decision to withdraw                 15                 12  
Subject/guardian's decision to withdraw                 33                 6  
Did not receive study drug                 3                 2  



  Baseline Characteristics
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Standard Chemotherapy + Bevacizumab     Standard Chemotherapy + Placebo     Total  
Number of Participants  
[units: participants]
 		  459     225     684  
Age  
[units: years]
Mean ± Standard Deviation 		  55.6  ± 11.0     55.0  ± 11.2     55.4  ± 11.1  
Gender  
[units: participants]
 		     
Female     457     225     682  
Male     2     0     2  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to data cut-off (up to 3 years, 2 months) ]
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2.  Secondary:   Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)   [ Time Frame: Baseline to data cut-off (up to 3 years, 2 months) ]
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3.  Secondary:   Overall Survival   [ Time Frame: Baseline to data cut-off (up to 3 years, 2 months) ]
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4.  Secondary:   One-year Survival   [ Time Frame: Baseline to data cut-off (up to 3 years, 2 months) ]
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5.  Secondary:   Objective Response   [ Time Frame: Baseline to data cut-off (up to 3 years, 2 months) ]
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6.  Secondary:   Duration of Objective Response   [ Time Frame: Baseline to data cut-off (up to 3 years, 2 months) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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