Status:
COMPLETED
XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer
Lead Sponsor:
Sanofi
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab. The secondary objectives are safety and pharmacokinetic interaction
Eligibility Criteria
Inclusion
- Metastatic breast cancer (MBC)
- HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
- Adequate organs functions
Exclusion
- More than one previous chemotherapy regimen for metastatic disease
- Cardiac dysfunction
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00386685
Start Date
July 1 2006
End Date
January 1 2011
Last Update
April 12 2011
Active Locations (4)
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1
Sanofi-Aventis Administrative Office
Diegem, Belgium
2
Sanofi-Aventis Administrative Office
Paris, France
3
Sanofi-Aventis Administrative Office
Bromma, Sweden
4
Sanofi-Aventis Administrative Office
Geneva, Switzerland