Evaluating Hormonal Status in Metastatic Breast Cancer Using PET Imaging

Evaluation of the Unconformity of the Hormonal Status of Metastatic Lesions During a First Relapse of Breast Cancer Initially Expressing Estrogen Receptors: a Pilot Study on the Interest of Positron Emission Tomography (PET) With 16α- [18F] -Fluoro-17β-estradiol (FES).

This study is testing if a special imaging technique can help doctors see differences in hormone receptor levels in breast cancer patients with metastasis to better guide their treatment after a relapse.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Centre Georges Francois Leclerc (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Dijon, Bourgogne and 1 other locations)
• Trial ID: NCT03873428 on ClinicalTrials.gov

What this trial studies

This pilot study aims to assess the variability of estrogen receptor expression in metastatic lesions of breast cancer patients experiencing their first relapse. It utilizes FES PET imaging to identify discrepancies in hormone receptor status between primary tumors and their metastases. The study will also explore how FES PET findings may influence treatment decisions and evaluate the response to chemotherapy after three months. By understanding tumor heterogeneity, the research seeks to improve patient management in hormone receptor-positive breast cancer.

Who should consider this trial

Good fit: Ideal candidates are women with stage IV breast cancer expressing estrogen receptors and who are candidates for hormone therapy as a first-line treatment.

Not a fit: Patients with triple-negative breast cancer or those with HER2 overexpression will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with metastatic breast cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding tumor heterogeneity and its impact on treatment outcomes.

Eligibility criteria

Inclusion Criteria:

1. ECOG score (Eastern Cooperative Oncology Group) ≤ 2.
2. Stage IV breast cancer (AJCC TNM).
3. Primitive tumor expressing RO (\> 10%).
4. Patient candidate for hormone therapy treatment targeting estrogen receptors as a first-line treatment in a context of first metastatic recurrence.
5. No overexpression of HER2 in the tumor.
6. Lack of previous treatment for metastatic disease
7. Metastatic status confirmed by 18F-FDG PET / CT performed in the month prior to inclusion
8. Life expectancy estimated at more than 3 months.
9. Patient able to understand and give informed informed consent for participation in the study.
10. Patient affiliated with the social security scheme or equivalent.

Exclusion Criteria:

1. Triple negative breast cancer
2. Overexpression HER2 +++
3. Metastatic involvement exclusively in the liver
4. Unable to lie down or maintain the position during the PET / CT scan
5. Uncontrolled intercurrent pathology that is life-threatening in the short term
6. Uncontrolled diabetes
7. History of an allergic reaction attributed to a chemical or biological compound related to FDG or FES
8. Psychiatric impairment or social conditions that would limit patient availability and compliance at different stages of the study.
9. Pregnant woman (mandatory pregnancy test at baseline) or who is breastfeeding.

Where this trial is running

Dijon, Bourgogne and 1 other locations

• Centre Georges-François Leclerc — Dijon, Bourgogne, France (RECRUITING)
• CGFL — Dijon, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Claire Tabouret-Viaud, MD

Conditions: FES TEP in Detection of Estrogen Receptors, breast cancer, first metastatic relapse, PET