A Study of Avastin (Bevacizumab) in Women With HER2 Negative Metastatic Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: June 5, 2006
Last updated: May 11, 2015
Last verified: May 2015
This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Placebo
Drug: bevacizumab [Avastin]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall response, duration of response, time to treatment failure, overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, FACT-B, QoL instrument, medical resource utilization [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 735
Study Start Date: March 2006
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Docetaxel
100mg/m2 iv on day 1 of each 3 week cycle
Drug: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of eah 3 week cycle
Experimental: 2 Drug: Docetaxel
100mg/m2 iv on day 1 of each 3 week cycle
Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle
Placebo Comparator: 3 Drug: Docetaxel
100mg/m2 iv on day 1 of each 3 week cycle
Drug: Placebo
iv on day 1 of each 3 week cycle


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

Inclusion Criteria:

  • female patients >= 18 years of age;
  • HER2 negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy;
  • no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • radiotherapy for treatment of metastatic disease;
  • other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
  • spinal cord compression or brain metastases;
  • major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization;
  • inadequate bone marrow, liver or renal function;
  • uncontrolled hypertension.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00333775

  Show 114 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00333775     History of Changes
Other Study ID Numbers: BO17708, 2005-003862-40
Study First Received: June 5, 2006
Last Updated: May 11, 2015
Health Authority: France: AFSSAPS (Agence francaise de securite sanitaire des produits de Sante)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2015