Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer

Study Overview
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Brief Summary
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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. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.

Detailed Description
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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

Official Title
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16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Fluoroestradiol (18F)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post menopausal age > 17 WHO 0-2 Metastatic adenocarcinoma of the breast Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment Life expectancy > 6 months Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour Presence of oestrogen receptors proven with immunohistochemistry (> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis) Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other) FDG PET/CT available on PACS or CD DICOM III format 11 Informed consent obtained Exclusion Criteria: Other evolutive malignant disease or acute or chronic infectious disease Chemotherapy during the last 3 months or change in treatment since FDG PET/CT. Isolated liver metastasis (high FES uptake by normal liver)

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fluoroestradiol (18F)<br> | Drug: Fluoroestradiol (18F)<br>* 2-4 MBq/kg body mass, one single IV injection<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers. |  | at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT,fluoroestradiol (18F), breast cancer, metastatic, prediction of response, hormone therapy