Imaging Estrogen Receptor Positive Advanced Breast Cancers
Official title: Evaluation of the Diagnostic, Prognostic and Follow-up Potential of 4,16α-[16α-18F]Difluoro-11β-methoxyestradiol (4FMFES) PET Imaging for Estrogen Receptor Positive Advanced Breast Cancers
Run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke · NCT04824014 · Data updated 2026-11-12
This study is testing a new type of PET imaging to see if it can help doctors better understand estrogen receptor levels in patients with advanced breast cancer, which may improve their treatment options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Status | Recruiting |
| Started | November 1, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT04824014 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 or older with advanced ER+ breast cancer who are eligible for systemic treatment.
✕Probably not a fit
Patients who are pregnant, nursing, or currently on certain anti-ER hormone therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the use of 4-fluoro-11β-methoxy-16α-[18F]fluoroestradiol (4FMFES) PET imaging to assess estrogen receptor (ER) status in patients with advanced ER+ breast cancer. The study aims to provide a non-invasive, whole-body assessment of ER expression, which can vary between tumor sites and over time. By determining ER status more accurately, the trial seeks to improve treatment decisions for patients with stage 3 or 4 breast cancer. Participants will undergo PET imaging to evaluate the correlation between 4FMFES uptake and ER expression.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients with advanced breast cancer.
How similar studies have gone: Previous studies using PET imaging for ER assessment have shown promise, indicating potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Université deSherbrooke
Sherbrooke, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Eric E Turcotte, MD — Université de Sherbrooke, Centre de Recherche du CHUS
- Study coordinator: Michel Paquette, PhD
- Email: michel.paquette@usherbrooke.ca
- Phone: 819-346-1110
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pre-surgery hormone therapy to lower positive margins in lobular breast cancer
This Phase 2 trial tests whether giving endocrine (hormone) therapy before breast-conserving surgery can reduce the chance of cancer at the edges of the removed tissue in postmenopausal people with ER+/HER2- invasive lobular breast cancer.
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Adherence to Cell Cycle Inhibitors with Endocrine Therapy in Localized High-Risk ER+ Breast Cancer
This study checks how well patients with localized ER+ breast cancer stick to a combined endocrine therapy and CDK4/6 inhibitor after surgery.
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Combining FWD1802 with CDK4/6 inhibitors or everolimus for ER+/HER2- advanced breast cancer
This trial tests whether adding FWD1802 to CDK4/6 inhibitors or everolimus helps people with ER-positive/HER2-negative unresectable locally advanced or metastatic breast cancer who have progressed on or cannot use standard therapy.
-
ctDNA-guided elacestrant for ER+ breast cancer
This trial will test whether giving elacestrant for one year to people with ER+, stage IIB/III breast cancer who have a positive ctDNA test after finishing endocrine therapy can eliminate hidden cancer and lower the chance of recurrence.
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Re‑irradiating the breast after a second lumpectomy
This trial will test whether targeted re‑irradiation (IMRT) after a second lumpectomy is safe for people with ER+ / HER2‑ breast cancer who previously received breast radiation.
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This study is trying to see how breast cancer responds to treatment before surgery by looking at tissue and blood samples from patients to find out what factors might affect their recovery and risk of cancer coming back.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.