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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech
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;   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: 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
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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  
Number of Participants  
[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
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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


  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.


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


No publications provided


Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00262067     History of Changes
Other Study ID Numbers: AVF3694g, BO20094
Study First Received: December 2, 2005
Results First Received: August 20, 2013
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration