Status:
COMPLETED
Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer
Lead Sponsor:
R-Pharm
Conditions:
Triple Negative Locally Advanced Non-resectable Breast Cancer
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negativ...
Eligibility Criteria
Inclusion
- Female subjects with triple negative (ER, PR, and HER2 negative) locally advanced non-resectable and/or metastatic breast cancer
- Prior adjuvant or neoadjuvant anthracycline-based chemotherapy
Exclusion
- Tumors that are fluorescence in situ hybridization test (FISH) positive or immunohistochemistry (IHC) 3+
- Neuropathy \> Grade 1
- Prior systemic therapy for metastatic disease
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00633464
Start Date
June 1 2008
End Date
May 1 2011
Last Update
March 10 2016
Active Locations (19)
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1
Local Institution
Graz, Austria, 8036
2
Local Institution
Vienna, Austria, 1090
3
Local Institution
Brno, Czechia, 656 53
4
Local Institution
Prague, Czechia, 128 08