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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, Inc.
ClinicalTrials.gov Identifier:
NCT00281697
First received: January 23, 2006
Last updated: July 5, 2013
Last verified: July 2013
Results First Received: August 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

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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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
  Show All 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) ]

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) ]

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

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

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

Measure Type Secondary
Measure Title Objective Response
Measure Description A patient had an objective response if they had a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
Time Frame Baseline to data cut-off for analysis of the primary Outcome Measure (up to 3 years, 2 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. Only patients who had measurable disease at baseline were included in the analysis.

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 
[Units: Participants]
 362   179 
Objective Response 
[Units: Percentage of patients]
Number (95% Confidence Interval)
 39.5 
 (34.4 to 44.7) 
 29.6 
 (23.0 to 36.7) 

No statistical analysis provided for Objective Response



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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Genentech, Inc.
phone: 800 821-8590



Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00281697     History of Changes
Other Study ID Numbers: AVF3693g
Study First Received: January 23, 2006
Results First Received: August 23, 2012
Last Updated: July 5, 2013