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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)

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ClinicalTrials.gov Identifier: NCT00281697
Recruitment Status : Completed
First Posted : January 25, 2006
Results First Posted : September 24, 2012
Last Update Posted : July 26, 2013
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Bevacizumab
Drug: Placebo
Drug: Standard chemotherapy

  Participant Flow

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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

1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]
  Show Outcome Measure 1

2.  Secondary:   Progression-free Survival Within Individual Standard Chemotherapy Cohorts (Taxanes, Gemcitabine, Capecitabine, and Vinorelbine)   [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]
  Show Outcome Measure 2

3.  Secondary:   Overall Survival   [ Time Frame: Baseline to the end of the study (up to 6 years, 7 months) ]
  Show Outcome Measure 3

4.  Secondary:   One-year Survival   [ Time Frame: Baseline to the end of the study (up to 6 years, 7 months) ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title One-year Survival
Measure Description Percentage of patients who survived 1 year in the study.
Time Frame Baseline to the end of the study (up to 6 years, 7 months)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat population: All randomized patients, regardless of whether they received any study drug or completed the full course of treatment.

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.

Measured Values
   Standard Chemotherapy + Bevacizumab   Standard Chemotherapy + Placebo 
Participants Analyzed   459   225 
One-year Survival 
[Units: Percentage of patients]
Number (95% Confidence Interval) 		 70.5 
 (66.3 to 74.7)  		 68.6 
 (62.5 to 74.8) 

No statistical analysis provided for One-year Survival



5.  Secondary:   Objective Response   [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]
  Show Outcome Measure 5

6.  Secondary:   Duration of Objective Response   [ Time Frame: Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 months) ]
  Show Outcome Measure 6


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information