BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2007 |
| End Date: | June 2014 |
An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.
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.
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.
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.
We found this trial at
44
sites
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