Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

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", "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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Estradiol; Fulvestrant

Criteria

Inclusion Criteria:

• Post-menopausal women

• Aromatase inhibitor as the last hormonal treatment

• Breast adenocarcinoma with positive hormone receptor

• Measurable disease as per RECIST definition

Exclusion Criteria:

• 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.