Breast Neoplasms
Conditions
Keywords
Breast cancer, Breast Tumors, Anti IGF-1R, Hormonosensitivity
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.
Interventions
DRUGAVE1642
AVE1642 is administered intravenously at the dose of 8 mg/kg.
DRUGFulvestrant
Fulvestrant is administered as a slow intramuscular injection (just before the AVE1642 infusion when given in combination).
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Progression Free rate | at 6 months |
| Safety (TEAEs, hematology, biochemistry parameters) | study period |
Countries
France, Italy, Spain
Outcome results
None listed