BEATRICE Study: A Study of Avastin (Bevacizumab) Adjuvant Therapy in Triple Negative Breast Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00528567

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: bevacizumab [Avastin] Drug: Standard adjuvant chemotherapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open Label 2-Arm Study to Evaluate the Impact of Adjuvant Bevacizumab on Invasive Disease Free Survival in Triple Negative Breast Cancer

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Invasive disease-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival, breast cancer-free interval, disease-free interval, distant disease-free survival. [ Time Frame: Event driven. ] [ Designated as safety issue: No ]
AEs, and laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	2706
Study Start Date:	December 2007
Estimated Study Completion Date:	September 2014

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 5mg/kg / week dosing equivalent iv Drug: Standard adjuvant chemotherapy As prescribed
2: Active Comparator	Drug: Standard adjuvant chemotherapy As prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528567

Contacts

Contact: Please reference Study ID Number: BO20289	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 372 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BO20289
Study First Received:	September 11, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00528567
Health Authority:	France: AFSSAPS

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Bevacizumab
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Growth Substances

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009