Imaging Estrogen Receptor Positive Advanced Breast Cancers
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
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 |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT04824014 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with advanced ER+ breast cancer who are eligible for systemic treatment.
Not a fit: Patients who are pregnant, nursing, or currently on certain anti-ER hormone therapies may not benefit from this study.
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 performed: Previous studies using PET imaging for ER assessment have shown promise, indicating potential success for this novel approach.
Eligibility criteria
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 this trial is running
Sherbrooke, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.