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)

Phase 4

Withdrawn

Brief 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.

Recruitment & Eligibility

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 </= 30% of marrow-bearing bone)
CNS metastases
Pre-existing peripheral neuropathy
Clinically significant cardiovascular disease

Arm && Interventions

Group	Intervention	Description
Single Arm	paclitaxel	-
Single Arm	bevacizumab [Avastin]	-

Primary Outcome Measures

Name	Time	Method
Safety profile: Adverse events	approximately 2 years

Secondary Outcome Measures

Name	Time	Method

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