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

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00528567

Run by

Hoffmann-La Roche

People needed

2591

Starts

2007-12-01

Expected to finish

2014-06-01

Last updated by the study team

2015-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, >=18 years of age;
• operable primary invasive breast cancer;
• completed definitive loco-regional surgery;
• primary tumor centrally confirmed as triple negative.

You may not qualify if…

• locally advanced breast cancers;
• previous breast cancer history;
• clinically significant cardiovascular disease.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Fayetteville, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Greenbrae, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pleasant Hill, California, United States
• Study site — Fairfield, Connecticut, United States
• Study site — Stamford, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Gainesville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Lawrenceville, Georgia, United States
• Study site — Niles, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Waterloo, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Rockville, Maryland, United States
• Study site — Brownstown, Michigan, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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