Clinical Trials Detalhe

BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

Visão Geral

Gender

ALL

Idade

N/A

Fase

PHASE3

Tipo de Estudo

INTERVENTIONAL

Localização

Coimbra, Portugal

Lisbon, Portugal

Clinicaltrial.gov

https://classic.clinicaltrials.gov/ct2/show/NCT00528567

Sumário

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.

Condições

Breast Cancer

Elegibilidade

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.