Breast Neoplasms Clinical Trial
Official title:
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 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", "partial response" and "stabilization of the disease".
The additional objectives are to evaluate the safety profile of AVE1642 in combination with
fulvestrant and of fulvestrant alone, to assess the rate of patients without disease
progression at 6 months and the overall progression-free survival time. An evaluation of the
pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also
be performed.
The biological activity of treatment will be assessed on tumor biopsies, when possible The
potential immunogenicity of AVE1642 will be studied
The study treatment will be administered until disease progression, unacceptable toxicity or patient willingness to discontinue. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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