Clinical Trials Detalhe
BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer
General Information
Gender
ALL
Age
N/A
Phase
PHASE3
Study Type
INTERVENTIONAL
Location
Coimbra, Portugal
Lisbon, Portugal
Lisbon, Portugal
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT00528567Summary
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.
Conditions
Breast Cancer
Eligibility
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.