A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00333775
First received: June 5, 2006
Last updated: December 21, 2015
Last verified: December 2015
Results First Received: July 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Docetaxel
Drug: Placebo to bevacizumab
Drug: Bevacizumab

  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
21 participants randomized to the placebo group received bevacizumab 7.5 mg/kg (n=5) or 15.0 mg/kg (n=16). Please see the Detailed Description for an explanation of the differences in the number of participants in the treatment groups in Participant Flow and Adverse Events.

Reporting Groups
  Description
Docetaxel 100 mg/m^2 Plus Placebo Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Participant Flow:   Overall Study
    Docetaxel 100 mg/m^2 Plus Placebo     Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg     Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg  
STARTED     241     248     247  
Received Treatment     238     247     245  
COMPLETED     0     0     0  
NOT COMPLETED     241     248     247  
Death                 144                 149                 143  
In Follow−up When Study Stopped                 87                 92                 96  
Lost to Follow-up                 10                 7                 8  



  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 participants, regardless of whether they received study drug or not.

Reporting Groups
  Description
Docetaxel 100 mg/m^2 Plus Placebo Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Total Total of all reporting groups

Baseline Measures
    Docetaxel 100 mg/m^2 Plus Placebo     Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg     Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg     Total  
Number of Participants  
[units: participants]
  241     248     247     736  
Age  
[units: years]
Mean (Standard Deviation)
  53.5  (10.47)     53.9  (10.61)     53.6  (10.78)     53.7  (10.61)  
Gender  
[units: participants]
       
Female     241     248     247     736  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months) ]

2.  Secondary:   Percentage of Participants With a Complete Response or a Partial Response   [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months) ]

3.  Secondary:   Duration of Response   [ Time Frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months) ]

4.  Secondary:   Time to Treatment Failure   [ Time Frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months) ]

5.  Secondary:   Overall Survival   [ Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 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
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  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: Hoffmann-La Roche
phone: 800 821-8590



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00333775     History of Changes
Other Study ID Numbers: BO17708
2005-003862-40 ( EudraCT Number )
Study First Received: June 5, 2006
Results First Received: July 22, 2015
Last Updated: December 21, 2015
Health Authority: France: AFSSAPS (Agence francaise de securite sanitaire des produits de Sante)