Phase 3
Completed N=2,591
BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
Source: ClinicalTrials.gov NCT00528567 ↗Enrolled (actual)
2,591
Serious AEs
14.1%
Results posted
Sep 2013
Primary outcomePrimary: Time to Invasive Disease-free Survival (IDFS) Event — NA; NA Months — p=0.1810
Summary
The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.
The secondary objectives of this trial are to:
* compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
* evaluate the safety and tolerability of bevacizumab
An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Invasive Disease-free Survival (IDFS) Event |
NA; NA | 0.1810 |
| PRIMARY Percentage of Participants With Invasive Disease-free Survival (IDFS) Events |
14.5; 15.9; 85.5; 84.1 | — |
| PRIMARY Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer |
NA; NA | 0.1966 |
| PRIMARY Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer |
13.5; 14.7; 86.5; 85.3 | — |
| SECONDARY Time to Overall Survival (OS) Event |
NA; NA | 0.5247 |
| SECONDARY Percentage of Participants With Overall Survival (OS) Event |
11.1; 11.6; 88.9; 88.4 | — |
| SECONDARY Time to Breast Cancer-Free Interval (BCFI) Event |
NA; NA | 0.2792 |
| SECONDARY Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events |
13.2; 14.2; 86.8; 85.8 | — |
| SECONDARY Time to Disease-Free Survival (DFS) Event |
NA; NA | 0.1832 |
| SECONDARY Percentage of Participants With Disease-Free Survival (DFS) Events |
14.7; 16.1; 85.3; 83.9 | — |
| SECONDARY Time to Distant Disease-Free Survival (DDFS) Event |
NA; NA | 0.3309 |
| SECONDARY Percentage of Participants With Distant Disease-Free Survival (DDFS) Events |
11.7; 12.7; 88.3; 87.3 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths |
379; 250; 45; 48; 1268; 1233 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- operable primary invasive breast cancer;
- completed definitive loco-regional surgery;
- primary tumor centrally confirmed as triple negative.
Exclusion Criteria
- locally advanced breast cancers;
- previous breast cancer history;
- clinically significant cardiovascular disease.
Data sourced from ClinicalTrials.gov (NCT00528567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.