Status:
WITHDRAWN
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)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01156961
Start Date
October 1 2010
End Date
December 1 2012
Last Update
November 2 2016
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