Status:
TERMINATED
Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer
Lead Sponsor:
Sanofi
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "par...
Detailed Description
The study treatment will be administered until disease progression, unacceptable toxicity or patient willingness to discontinue.
Eligibility Criteria
Inclusion
- Post-menopausal women
- Aromatase inhibitor as the last hormonal treatment
- Breast adenocarcinoma with positive hormone receptor
- Measurable disease as per RECIST definition
Exclusion
- ECOG performance status (PS) \> 2
- Prior exposure to fulvestrant or to an anti IGF-1R compound
- No evidence of hormonosensitivity
- HER 2-neu positive tumor
- More than one prior regimen of chemotherapy for metastatic disease
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00774878
Start Date
October 1 2008
End Date
November 1 2010
Last Update
March 3 2011
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Paris, France
2
Sanofi-Aventis Administrative Office
Milan, Italy
3
Sanofi-Aventis Administrative Office
Barcelona, Spain