16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?
Main objective: Compare the response rate after 6 months of hormone treatment (or a major
change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in
metastatic lesions taking-up FDG on PET/CT at baseline.
Secondary objectives:
- evaluate diagnostic performance of FES PET/CT
- determine whether FES PET/CT is able to detect metastases that are not visible on FDG
PET/CT. This point may constitute a direct benefit for the patient
- precise the nature of discordant FES/FDG foci
- validate and improve the interpretation criteria for FES PET/CT
- confirm the perfect tolerance
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate six months after induction or major change in hormone therapy for metastatic breast cancer.
Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. Response will be determined according to RECIST 1.1 criteria for each patient.
at 6 months
No
Khaldoun KERROU, MD
Principal Investigator
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health
P110113
NCT01627704
June 2012
June 2015
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