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BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
This study has been completed.
Sponsor:
Hoffmann-La Roche
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
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Results First Received: February 28, 2013
| Study Type: | Interventional |
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| Study Design: | Allocation: Randomized; 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 |
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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 |
Show Baseline Characteristics
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) ] |
| 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 ] |
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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