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Therapeutic Areas: Oncology | Obstetrics/Gynecology
Disease Category: Breast Cancer
Trial Information
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 2706.
Study Phase: III
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Open Label
- Control: Active
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
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:
- 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.
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: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Fitzroy 3065
Australia
Phone: 973-235-5000 or 800-526-6367
View Google Map
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