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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Docetaxel

Criteria

Inclusion criteria:

• Female patients ≥ 18 years of age.

• Human epidermal growth factor receptor 2 (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.

• Eastern Cooperative Oncology Group (ECOG) performance status of 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.