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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00528567
First received: September 11, 2007
Last updated: September 17, 2013
Last verified: September 2013
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 [Avastin]
Drug: Standard adjuvant 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 and Chemotherapy bevacizumab 5 mg/kg/week intravenous every 2- 3 weeks based on body weight in combination with chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). Participants discontinued chemotherapy and were treated with bevacizumab only for total treatment with bevacizumab approximately 52 weeks or 18 3-week cycles. Participants then entered a follow-up period.
Chemotherapy Participants received chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). After completion of chemotherapy participants entered the follow-up period.

Participant Flow:   Overall Study
    Bevacizumab and Chemotherapy     Chemotherapy  
STARTED     1301     1290  
Safety Population     1288     1271  
COMPLETED     870     982  
NOT COMPLETED     431     308  
Death                 4                 5  
Breast Cancer Recurrence/2nd Primary                 30                 60  
Adverse Event/Intermittent Illness                 255                 29  
Violation Criteria at Entry                 3                 17  
Withdrew Consent                 59                 55  
Refused Treatment/Did Not Cooperate                 52                 42  
Failure to Return                 1                 4  
Other Protocol Violation                 5                 21  
Administrative/Other                 22                 75  



  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
Bevacizumab and Chemotherapy bevacizumab 5 mg/kg/week intravenous every 2- 3 weeks based on body weight in combination with chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). Participants discontinued chemotherapy and were treated with bevacizumab only for total treatment with bevacizumab approximately 52 weeks or 18 3-week cycles. Participants then entered a follow-up period.
Chemotherapy Participants received chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). After completion of chemotherapy participants entered the follow-up period.
Total Total of all reporting groups

Baseline Measures
    Bevacizumab and Chemotherapy     Chemotherapy     Total  
Number of Participants  
[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:   Percentage of Participants With Overall Survival (OS) Events   [ Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months) ]

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

8.  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) ]

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

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

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

12.  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) ]

13.  Secondary:   Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths   [ Time Frame: Up to 18 months for AEs and Up to 49 months for SAEs ]
  Hide Outcome Measure 13

Measure Type Secondary
Measure Title Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths
Measure Description

An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Time Frame Up to 18 months for AEs and Up to 49 months for SAEs  
Safety Issue No  

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.
Safety population included all randomized participants who received at least one dose of study drug. Two participants in the Chemotherapy group received bevacizumab in error and one participant in the bevacizumab and chemotherapy group did not receive bevacizumab.

Reporting Groups
  Description
Bevacizumab and Chemotherapy bevacizumab 5 mg/kg/week intravenous every 2- 3 weeks based on body weight in combination with chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). Participants discontinued chemotherapy and were treated with bevacizumab only for total treatment with bevacizumab approximately 52 weeks or 18 3-week cycles. Participants then entered a follow-up period.
Chemotherapy Participants received chemotherapy as prescribed (anthracycline containing without taxane every 3-4 weeks or anthracycline with taxane every 2-3 weeks or taxane containing without anthracycline every 3 weeks). After completion of chemotherapy participants entered the follow-up period.

Measured Values
    Bevacizumab and Chemotherapy     Chemotherapy  
Number of Participants Analyzed  
[units: participants]
  1288     1271  
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths  
[units: Participants]
   
Serious Adverse Events     379     250  
Adverse Events     1274     1252  
Deaths     31     41  

No statistical analysis provided for Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths




  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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00528567     History of Changes
Other Study ID Numbers: BO20289
Study First Received: September 11, 2007
Results First Received: February 28, 2013
Last Updated: September 17, 2013
Health Authority: France: AFSSAPS