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
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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) ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Time to Breast Cancer-Free Interval (BCFI) Event
Measure Description BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.
Time Frame Event driven (until data cutoff: 29 February 2012 up to 49 months)  
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.
Intent-to-treat participants included all randomized participants.

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]
  1301     1290  
Time to Breast Cancer-Free Interval (BCFI) Event  
[units: Months]
Median ( 95% Confidence Interval )
  NA  
  ( NA to NA ) [1]
  NA  
  ( NA to NA ) [1]
[1] The median was not reached.


Statistical Analysis 1 for Time to Breast Cancer-Free Interval (BCFI) Event
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.2792
Hazard Ratio (HR) [4] 0.89
95% Confidence Interval ( 0.72 to 1.10 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.



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 ]


  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