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

Study Overview
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Brief Summary
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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

Detailed Description
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The study treatment will be administered until disease progression, unacceptable toxicity or patient willingness to discontinue.

Official Title
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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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: AVE1642
* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br> | Drug: AVE1642<br>* AVE1642 is administered intravenously at the dose of 8 mg/kg.<br>Drug: Fulvestrant<br>* Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).<br>|
| Active Comparator: Arm B<br> | Drug: Fulvestrant<br>* Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free rate |  | at 6 months | 
| Safety (TEAEs, hematology, biochemistry parameters) |  | study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Breast Tumors, Anti IGF-1R, Hormonosensitivity