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A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Genentech, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00262067
First received: December 2, 2005
Last updated: November 18, 2013
Last verified: November 2013
Results First Received: August 20, 2013  
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: 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
Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
Bevacizumab 15 mg/kg + Capecitabine Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
Placebo to Bevacizumab + Capecitabine Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.

Participant Flow:   Overall Study
    Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen   Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen   Bevacizumab 15 mg/kg + Capecitabine   Placebo to Bevacizumab + Capecitabine
STARTED   415   207   409   206 
COMPLETED   196   107   193   93 
NOT COMPLETED   219   100   216   113 
Death                190                89                186                99 
Lost to Follow-up                5                4                7                5 
Sponsor's Decision to Terminate Study                1                0                0                0 
Patient Withdrew for Survival Follow-up                23                7                23                9 



  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.
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
Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
Bevacizumab 15 mg/kg + Capecitabine Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
Placebo to Bevacizumab + Capecitabine Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
Total Total of all reporting groups

Baseline Measures
   Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen   Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen   Bevacizumab 15 mg/kg + Capecitabine   Placebo to Bevacizumab + Capecitabine   Total 
Overall Participants Analyzed 
[Units: Participants]
 415   207   409   206   1237 
Age, Customized 
[Units: Participants]
         
< 40 years   29   14   21   15   79 
40-64 years   295   160   289   137   881 
≥ 65 years   91   33   99   54   277 
Gender 
[Units: Participants]
         
Female   413   207   408   204   1232 
Male   2   0   1   2   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months) ]

2.  Secondary:   Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months) ]

3.  Secondary:   Duration of Objective Response as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 months) ]

4.  Secondary:   Overall Survival   [ Time Frame: Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months) ]

5.  Secondary:   1-year Survival   [ Time Frame: Baseline to the data cut-off of 23 Feb 2009 (up to 3 years, 2 months) ]

6.  Secondary:   Progression-free Survival (PFS) as Determined by the Independent Review Committee Using Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Baseline to the data cut-off date of 31 Jul 2008 (up to 2 years, 7 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: NCT00262067     History of Changes
Other Study ID Numbers: AVF3694g
BO20094 ( Other Identifier: Hoffmann-La Roche )
Study First Received: December 2, 2005
Results First Received: August 20, 2013
Last Updated: November 18, 2013