A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Paclitaxel

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Locally recurrent or metastatic Her2-negative breast cancer

• Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of >/=12 months is required

• Adequate haematological, renal and liver function

Exclusion Criteria:

• Previous chemotherapy for locally recurrent or metastatic disease

• Radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of
• CNS metastases

• Pre-existing peripheral neuropathy

• Clinically significant cardiovascular disease