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
  Hide Participant Flow

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

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
  Hide Baseline Characteristics

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
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Time to Invasive Disease-free Survival (IDFS) Event
Measure Description IDFS, was a composite endpoint 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 or Second primary non-breast invasive cancer.
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 Invasive Disease-free Survival (IDFS) Event  
[units: Months]
Median (95% Confidence Interval)
  NA  
  [1]
  NA  
  [1]
[1] The median was not reached.


Statistical Analysis 1 for Time to Invasive Disease-free Survival (IDFS) Event
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.1810
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:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Stratification factors were axillary nodal status, choice of adjuvant chemotherapy, hormone receptor status, surgery.
[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:
  No text entered.



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) ]

Measure Type Primary
Measure Title Percentage of Participants With Invasive Disease-free Survival (IDFS) Events
Measure Description IDFS, was a composite endpoint 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 or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.
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  
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events  
[units: Percentage of participants]
   
Percentage of Participants with Events     14.5     15.9  
Percentage of Participants without Events     85.5     84.1  

No statistical analysis provided for Percentage of Participants With Invasive Disease-free Survival (IDFS) Events



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) ]

Measure Type Primary
Measure Title Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
Measure Description IDFS, was a composite endpoint 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.
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 Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer  
[units: Months]
Median (95% Confidence Interval)
  NA  
  [1]
  NA  
  [1]
[1] The median was not reached.


Statistical Analysis 1 for Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.1966
Hazard Ratio (HR) [4] 0.87
95% Confidence Interval 0.71 to 1.07
[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:
  No text entered.
[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.



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) ]

Measure Type Primary
Measure Title Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer
Measure Description IDFS, was a composite endpoint 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. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.
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  
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer  
[units: Percentage of participants]
   
Percentage of Participants with Events     13.5     14.7  
Percentage of Participants without Events     86.5     85.3  

No statistical analysis provided for Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer



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

Measure Type Secondary
Measure Title Time to Overall Survival (OS) Event
Measure Description OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
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

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

No statistical analysis provided for Time to Overall Survival (OS) Event



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

Measure Type Secondary
Measure Title Time to Overall Survival (OS) Event
Measure Description OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
Time Frame Event driven (until data cutoff: 30 June 2014: up to 77 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

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


Statistical Analysis 1 for Time to Overall Survival (OS) Event
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.5247
Hazard Ratio (HR) [4] 0.93
95% Confidence Interval 0.74 to 1.17
[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:
  Stratification factors are Axillary nodal status, Choice of adjuvant chemotherapy, Hormone receptor status, Surgery
[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:
  No text entered.



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) ]

Measure Type Secondary
Measure Title Percentage of Participants With Overall Survival (OS) Event
Measure Description OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
Time Frame Event driven (until data cut off: 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

Measured Values
    Bevacizumab and Chemotherapy     Chemotherapy  
Number of Participants Analyzed  
[units: participants]
  1301     1290  
Percentage of Participants With Overall Survival (OS) Event  
[units: percentage of participants]
   
with events     7.1     8.3  
without events     92.9     91.7  


Statistical Analysis 1 for Percentage of Participants With Overall Survival (OS) Event
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.2318
Hazard Ratio (HR) [4] 0.84
95% Confidence Interval 0.64 to 1.12
[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:
  No text entered.
[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:
  No text entered.



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) ]

Measure Type Secondary
Measure Title Percentage of Participants With Overall Survival (OS) Event
Measure Description OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.
Time Frame Event driven (until data cut off: 30 June 2014: up to 77 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

Measured Values
    Bevacizumab and Chemotherapy     Chemotherapy  
Number of Participants Analyzed  
[units: participants]
  1301     1290  
Percentage of Participants With Overall Survival (OS) Event  
[units: percentage of participants]
   
with events     11.1     11.6  
without events     88.9     88.4  

No statistical analysis provided for Percentage of Participants With Overall Survival (OS) Event



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

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, 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 Breast Cancer-Free Interval (BCFI) Event  
[units: Months]
Median (95% Confidence Interval)
  NA  
  [1]
  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:
  No text entered.
[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.



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) ]

Measure Type Secondary
Measure Title Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events
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 DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.
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  
Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events  
[units: Percentage of participants]
   
Percentage of Participants with Events     13.2     14.2  
Percentage of Participants without Events     86.8     85.8  

No statistical analysis provided for Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events



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

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:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[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.



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) ]

Measure Type Secondary
Measure Title Percentage of Participants With Disease-Free Survival (DFS) Events
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). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.
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  
Percentage of Participants With Disease-Free Survival (DFS) Events  
[units: Percentage of participants]
   
with Events     14.7     16.1  
without Events     85.3     83.9  

No statistical analysis provided for Percentage of Participants With Disease-Free Survival (DFS) Events



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

Measure Type Secondary
Measure Title Time to Distant Disease-Free Survival (DDFS) Event
Measure Description DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).
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 Distant Disease-Free Survival (DDFS) Event  
[units: Months]
Median (95% Confidence Interval)
  NA  
  [1]
  NA  
  [2]
[1] The median was not reached.
[2] The median was not reached


Statistical Analysis 1 for Time to Distant Disease-Free Survival (DDFS) Event
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.3309
Hazard Ratio (HR) [4] 0.90
95% Confidence Interval 0.72 to 1.12
[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:
  No text entered.
[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.



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) ]

Measure Type Secondary
Measure Title Percentage of Participants With Distant Disease-Free Survival (DDFS) Events
Measure Description DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.
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  
Percentage of Participants With Distant Disease-Free Survival (DDFS) Events  
[units: Percentage of participants]
   
Percentage of Participants with Events     11.7     12.7  
Percentage of Participants without Events     88.3     87.3  

No statistical analysis provided for Percentage of Participants With Distant Disease-Free Survival (DDFS) Events



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 ]

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 Through end of study: 30 June 2014: up to 77 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.
Safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all other patients were analyzed in the chemotherapy arm.

Reporting Groups
  Description
Bevacizumab and Chemotherapy (0-18 Months) Occurring in participants who received bevacizumab and chemotherapy, 0-18 months after first dose
Chemotherapy (0-18 Months) Occurring in participants who received chemotherapy alone, 0-18 months after first dose
Bevacizumab and Chemotherapy (>18 Months) Occurring in participants who received bevacizumab and chemotherapy, more than 18 months after first dose
Chemotherapy (>18 Months) Occurring in participants who received chemotherapy alone, more than 18 months after first dose

Measured Values
    Bevacizumab and Chemotherapy (0-18 Months)     Chemotherapy (0-18 Months)     Bevacizumab and Chemotherapy (>18 Months)     Chemotherapy (>18 Months)  
Number of Participants Analyzed  
[units: participants]
  1288     1271     1288     1271  
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths  
[units: Participants]
       
Serious Adverse Events     379     250     45     48  
Adverse Events (5% Reporting Threshold)     1268     1233     0     0  
Deaths     31     41     113     106  

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




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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