Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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
Full description
The study treatment will be administered until disease progression, unacceptable toxicity or patient willingness to discontinue.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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