Trial Information

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

Status: Recruiting

Protocol Number: BO20289

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open label 2-arm study to evaluate the impact of adjuvant bevacizumab on Invasive Disease Free Survival in triple negative breast cancer

Brief Summary: This 2 arm open-label study will evaluate the efficacy and safety of the addition of Avastin (bevacizumab) to standard adjuvant therapy in patients with triple negative breast cancer. Patients will be randomized to receive either standard chemotherapy (anthracycline +/- taxane or taxane only), or standard chemotherapy given concurrently with 1 year of Avastin (5mg/kg/week dosing equivalent i.v.). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 2530.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Breast Cancer

Intervention Type: Drug

Intervention Name: bevacizumab [Avastin]

Primary Outcome: 1. Invasive disease-free survival Time frame: Event driven

Key Secondary Outcomes: 1. Overall survival, breast cancer-free interval, disease-free interval, distant disease-free survival. Time frame: Event driven. 2. AEs, and laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2007

Trial Registration Date: 09/11/2007

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:58:31 PM