A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: bevacizumab [Avastin]; Drug: Taxane-based chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448591

MO19391

Details and patient eligibility

About

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Enrollment: 2,296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients, >=18 years of age;
• HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
• candidates for chemotherapy.

Exclusion criteria

• previous chemotherapy for metastatic or locally recurrent breast cancer;
• concomitant hormonal therapy for metastatic or locally recurrent disease;
• concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
• previous radiotherapy for treatment of metastatic disease;
• evidence of CNS metastases.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,296 participants in 1 patient group

1

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: Taxane-based chemotherapy