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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00528567
First received: September 11, 2007
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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 ]

Enrollment: 2587
Study Start Date: December 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
5mg/kg / week dosing equivalent iv
Drug: Standard adjuvant chemotherapy
As prescribed
Active Comparator: 2 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

  Show 404 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00528567     History of Changes
Other Study ID Numbers: BO20289
Study First Received: September 11, 2007
Last Updated: February 4, 2013
Health Authority: France: AFSSAPS

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Bevacizumab
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013