A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00846027

2008-003657-32 (EudraCT Number)

ML21999

Details and patient eligibility

About

This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.

Enrollment: 90 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients, ≥ 18 years of age.
• Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
• HER-2 negative disease.
• Candidates for chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion criteria

• Previous chemotherapy for metastatic or locally advanced breast cancer.
• Previous radiotherapy for treatment of metastatic breast cancer.
• Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment.
• Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Bevacizumab + paclitaxel + gemcitabine

Experimental group

Description:

Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m\^2 IV, and gemcitabine 2000 mg/m\^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

Treatment:

Drug: Gemcitabine

Drug: Paclitaxel

Drug: Bevacizumab