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BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00528567
First received: September 11, 2007
Last updated: August 5, 2015
Last verified: August 2015
Results First Received: February 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Bevacizumab
Drug: Standard adjuvant chemotherapy

  Participant Flow


  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.
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Reporting Groups
  Description
Bevacizumab and Chemotherapy Participants randomized to receive bevacizumab and chemotherapy
Chemotherapy Participants randomized to receive chemotherapy alone
Total Total of all reporting groups

Baseline Measures
   Bevacizumab and Chemotherapy   Chemotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 1301   1290   2591 
Age, Customized 
[Units: Participants]
     
< 40 years   231   253   484 
>= 40 to < 65 years   952   916   1868 
>= 65 years   118   121   239 
Gender 
[Units: Participants]
     
Female   1301   1290   2591 
Male   0   0   0 


  Outcome Measures
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1.  Primary:   Time to Invasive Disease-free Survival (IDFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

2.  Primary:   Percentage of Participants With Invasive Disease-free Survival (IDFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

3.  Primary:   Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

4.  Primary:   Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

5.  Secondary:   Time to Overall Survival (OS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

6.  Secondary:   Time to Overall Survival (OS) Event   [ Time Frame: Event driven (until data cutoff: 30 June 2014: up to 77 months) ]

7.  Secondary:   Percentage of Participants With Overall Survival (OS) Event   [ Time Frame: Event driven (until data cut off: 29 February 2012: up to 49 months) ]

8.  Secondary:   Percentage of Participants With Overall Survival (OS) Event   [ Time Frame: Event driven (until data cut off: 30 June 2014: up to 77 months) ]

9.  Secondary:   Time to Breast Cancer-Free Interval (BCFI) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

10.  Secondary:   Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

11.  Secondary:   Time to Disease-Free Survival (DFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

12.  Secondary:   Percentage of Participants With Disease-Free Survival (DFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

13.  Secondary:   Time to Distant Disease-Free Survival (DDFS) Event   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

14.  Secondary:   Percentage of Participants With Distant Disease-Free Survival (DDFS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months) ]

15.  Secondary:   Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths   [ Time Frame: Through end of study: 30 June 2014: up to 77 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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