Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical Trials

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00333775
Information obtained from ClinicalTrials.gov on May 13, 2013

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