Breast Cancer Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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