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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00333775
First received: June 5, 2006
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This study will evaluate the efficacy and safety of 2 doses of Avastin in combin ation with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy bu t who have not received prior chemotherapy for metastatic disease. The anticipat ed 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: October 2013
Primary Completion Date: October 2013 (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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333775

  Show 114 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: NCT00333775     History of Changes
Other Study ID Numbers: BO17708, 2005-003862-40
Study First Received: June 5, 2006
Last Updated: August 26, 2014
Health Authority: France: AFSSAPS (Agence francaise de securite sanitaire des produits de Sante)

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

ClinicalTrials.gov processed this record on August 28, 2014