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
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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
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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

Participants randomized to receive bevacizumab and chemotherapy.

For these patients, bevacizumab was given in combination with chemotherapy at a dose of 5 mg/kg/week equivalent using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy selected. After completing chemotherapy + bevacizumab (treatment period 1), patients in this arm received bevacizumab monotherapy up to a total duration of 1 year (treatment period 2).

At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study.

Chemotherapy

Participants randomized to receive chemotherapy alone.

For patients randomized to the chemotherapy alone arm, investigators could select from one of three chemotherapy regimens. After completing chemotherapy (treatment period 1) patients entered a post-treatment surveillance period for the remainder of the first year after randomization (treatment period 2).

At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study.


Participant Flow:   Overall Study
    Bevacizumab and Chemotherapy     Chemotherapy  
STARTED     1301     1290  
Intention to Treat     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 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  
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:   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) ]
  Hide Outcome Measure 11

Measure Type Secondary
Measure Title Time to Disease-Free Survival (DFS) Event
Measure Description DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).
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 population, defined as all randomized participants.

Reporting Groups
  Description
Bevacizumab and Chemotherapy Participants randomized to receive bevacizumab and chemotherapy
Chemotherapy Participants randomized to receive chemotherapy alone

Measured Values
    Bevacizumab and Chemotherapy     Chemotherapy  
Number of Participants Analyzed  
[units: participants]
  1301     1290  
Time to Disease-Free Survival (DFS) Event  
[units: Months]
Median (95% Confidence Interval)
  NA  
  [1]
  NA  
  [1]
[1] The median was not reached.


Statistical Analysis 1 for Time to Disease-Free Survival (DFS) Event
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.1832
Hazard Ratio (HR) [4] 0.87
95% Confidence Interval 0.72 to 1.07
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[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:
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[4] Other relevant estimation information:
  Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.



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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  More Information