Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC). Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria. After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators. Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.

Official Title
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Impact of 18F-fluoroestradiol (FES) Positron Emission Tomography (PET) on the Therapeutic Treatment of Metastatic Breast Cancer Ipatients, Initially ER Positive and HER2 Negative, in Relapse After First-line Therapy Combining Hormone Therapy

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman aged at least 18 years old on inclusion Primary breast cancer expressing hormonal estrogen receptors in IHC (ER ≥ 10%) Primary breast tumor HER2 negative (0, 1+, 2+ FISH negative) Metastatic stage with at least one lesion identifiable on conventional work-up other than a hepatic lesion Patient in a situation of recurrence of the first line of treatment combining a CDK4 / 6 inhibitor and a hormone therapy Patient having performed a PET / CT with FDG during the follow-up of first metastatic line defining the relapse or performing a PET / CT with the baseline FDG defining the relapse during the extension assessment of 2nd line (according to the recommendations of the GBU of the examinations of 'medical imaging). A period of 2 to 28 days will be respected between the 2 PET / CT (FDG / FES). ECOG 0, 1 or 2 Life expectancy of at least 12 months Exclusion Criteria: Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES) Patients in the first metastatic line or beyond the second metastatic line Person with a known allergy to any of the components of EstroTep Patients who have been treated with a CDK4 / 6 inhibitor in combination with a first-line metastatic SERM or SERD Severe or known hepatic or renal failure Patient under a low salt diet or having an alcohol intake incompatible with EstroTep administration according to the investigator judgment Woman of childbearing potential without effective contraception according to the investigator judgement Serious intercurrent illness or co-morbidity assessed as risk

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective population<br> | Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT<br>* Administration of one dose of 18F FES for PET/CT imaging<br>* Other names: ESTROTEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the impact of ESTROTEP PET/CT on metastatic breast cancer patients management, initially ER+ and HER2-, in relapse after first-line treatment combining hormone therapy. | The percentage of patients for whom a substantial therapeutic measure was implemented following an analysis of the FES PET examination. This assessment will be performed prospectively by means of a standardised questionnaire completed by the prescribing clinician, when the request for an FES PET/CT is made. The therapeutic modality initially planned and the modality actually used may be determined by a multidisciplinary consultation meeting depending on the centre. This questionnaire will completed again within a maximum period of 15 days following the FES PET/CT in order to specify the final therapeutic measure. Substantial measures will be considered to be any major modifications made in terms of: therapeutic modalities, diagnostic modalities and follow-up modalities. | Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT |