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

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Bevacizumab; Drug: Standard adjuvant chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528567

BO20289

2007-001128-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 2,591 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,591 participants in 2 patient groups

Bevacizumab and Chemotherapy

Experimental group

Description:

Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.

Treatment:

Drug: Bevacizumab

Drug: Standard adjuvant chemotherapy

Chemotherapy

Active Comparator group

Description:

Participants randomized to receive standard adjuvant chemotherapy as prescribed.

Treatment:

Drug: Standard adjuvant chemotherapy