Clinical trial NCT00774878: Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Breast cancer
Breast Tumors
Anti IGF-1R
Hormonosensitivity
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: 6 cycles
Secondary outcomes:
measure: Progression Free rate
timeFrame: at 6 months
measure: Safety (TEAEs, hematology, biochemistry parameters)
timeFrame: study period
Other outcomes:
Locations:
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Institut Claudius Regaud (TOULOUSE - FRANCE)
name: Henri ROCHE, Professor
role: PRINCIPAL_INVESTIGATOR
References: