Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Hoffmann-La Roche
- Primary Endpoint
- Safety profile: Adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Single Arm
Intervention: bevacizumab [Avastin] (Drug)
Single Arm
Intervention: paclitaxel (Drug)
Outcomes
Primary Outcomes
Safety profile: Adverse events
Time Frame: approximately 2 years
Secondary Outcomes
No secondary outcomes reported