Multicenter, Randomized, Open Label Study Evaluating an Anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) Monoclonal Antibody, AVE1642, Administered Every 4 Weeks in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer
The study treatment will be administered until disease progression, unacceptable toxicity or
patient willingness to discontinue.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical benefit defined as a confirmed complete response (CR) or a confirmed partial response (PR) or a stable disease (SD)lasting at least 24 weeks (6 cycles)
6 cycles
No
Henri ROCHE, Professor
Principal Investigator
Institut Claudius Regaud (TOULOUSE - FRANCE)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
TCD10631
NCT00774878
October 2008
November 2010
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