Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment150 (estimated)
SponsorCentre de recherche du Centre hospitalier universitaire de Sherbrooke
Academic / other
Locations1 site (Sherbrooke, Quebec)
StatusRecruiting
StartedNovember 1, 2020
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 10, 2026
Trial IDNCT04824014 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

  • Université deSherbrooke
    Sherbrooke, Quebec, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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    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

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  • Combining FWD1802 with CDK4/6 inhibitors or everolimus for ER+/HER2- advanced breast cancer

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    Recruiting Phase 1/2 Forward Pharmaceuticals Co., Ltd. · Shanghai · NCT07002177

  • ctDNA-guided elacestrant for ER+ breast cancer

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  • Re‑irradiating the breast after a second lumpectomy

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  • Understanding breast cancer response during pre-surgery treatment

    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.

    Recruiting Royal Marsden NHS Foundation Trust · London · NCT06681064

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.