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4FMFES-PET Imaging of ER+ Advanced Breast Cancers

RecruitingPhase 2Ages 18 Years - anyAllCentre de recherche du Centre hospitalier univers…
NCT04824014 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Estrogen Receptor (ER) is a crucial prognostic factor and treatment target in breast cancer patients. Knowledge of its status greatly influences the choice of the optimal course of treatment. Pathological evaluations of primary tumor, axillary nodes, and metastases are the only confirmatory approach to ER status determination and are limited to known and accessible sites. However, it is known that many advanced breast cancer patients harbor diseases presenting inter-tumor or temporal ER heterogeneity, as ER expression can vary between tumor foci and can evolve during treatment and at time of recurrence, hence the need for whole-body, non-invasive assessment of ER status. In the last decades, 16α-\[18F\]fluoroestradiol (FES) was developed and evaluated as an ER-targeting positron emission tomography (PET) tracer. FES correlated with ER expression, and recently was shown to be able to pre

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📋 Eligibility rules (as published)
Inclusion Criteria: * Advanced breast cancer patients, i.e. stage 3 or 4 diseases. * Aged 18 or older at the time of breast cancer diagnosis. * Histopathologic review confirming diagnosis of ER positive breast cancer. * Male patients, although rare, can participate. * Patient must have given informed consent. * ECOG performance status 0-3. * ER must be positive in at least 10% of tumor cells in either the core biopsy or a therapeutic surgical resection. * Any HER2-neu status. * Patient eligible for and willing to receive systemic treatment. Exclusion Criteria: * Patients who are pregnant or nursing. * Patients unable to tolerate PET/CT for 30 minutes. * Patients taking anti-ER hormone therapy that can pharmacologically blockade estrogen receptors (ex: Tamoxifen, Fulvestrant). Patients can undergo 4FMFES-PET if anti-ER therapy was interrupted at least 8 weeks prior imaging. Aromatase inhibitors and LHRH analogs are not expected to interfere with 4FMFES uptake and are thus permitted to be taken prior and during this study.
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What it tests

  • 4FMFES-PET
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Where

1 site
Université deSherbrooke
Sherbrooke, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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