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

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Bevacizumab; Drug: Placebo to bevacizumab; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333775

2005-003862-40 (EudraCT Number)

BO17708

Details and patient eligibility

About

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.

Full description

Five participants randomized to the docetaxel 100 mg/m^2 plus placebo group actually received docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg group for the adverse event results. Sixteen participants randomized to the docetaxel 100 mg/m^2 plus placebo group actually received docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg and are included in the docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg group for the adverse event results.

Enrollment: 736 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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736 participants in 3 patient groups

Docetaxel 100 mg/m^2 plus placebo

Experimental group

Description:

Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Treatment:

Drug: Docetaxel

Drug: Placebo to bevacizumab

Docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg

Experimental group

Description:

Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Treatment:

Drug: Docetaxel

Drug: Bevacizumab

Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg

Experimental group

Description:

Participants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.

Treatment:

Drug: Docetaxel

Drug: Bevacizumab