Trial Information

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

Status: No longer recruiting

Protocol Number: BO17708

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of first line treatment with Avastin (bevacizumab) in combination with docetaxel on progression-free survival and disease response in patients with HER2 negative metastatic breast cancer

Brief Summary: 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. Target sample size is 705.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Placebo
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Breast Cancer

Intervention Type: Drug

Intervention Name: bevacizumab [Avastin]

Primary Outcome: Progression-free survival. Timeframe: Event driven.

Key Secondary Outcomes: Best overall response; duration of response; time to treatment failure, overall survival. Timeframe: Event driven. AEs, laboratory parameters, FACT-B QoL instrument, medical resource utilization. TImeframe: Throughout study.

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.

Gender: Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: March, 2006

Trial Registration Date: 03/10/2006

Date Last Updated: 02/15/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Melbourne, Australia, 3128
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: May 13, 2008 at 1:42:57 PM


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