18F‑FES PET/CT to detect distant metastasis in low‑grade ER‑positive stage III breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study enrolls adults with newly diagnosed, histologically confirmed ER‑positive, grade 1–2 stage III (IIIA–IIIC) breast cancer who have recent chest/abdominal CT and bone scan. Participants will undergo an 18F‑FES PET/CT scan to visualize estrogen receptor expression and identify distant or regional metastases. The primary measure is the patient‑level detection rate of qualitative 18F‑FES PET/CT for distant metastases, with results compared to conventional staging. The trial excludes patients already receiving systemic therapy and is conducted at a single tertiary center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients aged ≥19 years, regardless of race/ethnicity
2. Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation.
3. Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer
4. Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system
5. Patients who have undergone, or are scheduled to undergo chest computed tomography (CT), abdominal CT, and bone scintigraphy within 90 days prior to screening before the 18F-FES PET/CT scan
6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2

Exclusion Criteria:

* The subject or the subject's legally authorized representative has not signed the informed consent form
* Subjects who are currently receiving systemic therapy for breast cancer (e.g., neoadjuvant chemotherapy, hormonal therapy)
* Subjects with a history of another invasive malignancy within the past 2 years (except for non-melanoma skin cancer)
* Subjects diagnosed with distant metastases on chest CT, abdominal CT, or bone scintigraphy performed within 90 days prior to screening or before the 18F-FES PET/CT scan
* Subjects for whom neither biopsy nor ≥6 months of follow-up imaging has been performed for lesions suspicious for distant metastases
* Pregnant or breastfeeding women. The following cases are considered not at risk of pregnancy: (1) physiologically postmenopausal (no menses for ≥2 years), (2) surgically sterile (history of bilateral oophorectomy or hysterectomy), (3) women of childbearing potential with a documented negative serum or urine pregnancy test within 24 hours prior to 18F-FES administration, and who agree to use effective contraception during the trial.
* Subjects with serious and/or uncontrolled and/or unstable medical conditions (e.g., congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic kidney disease, or chronic liver disease)
* Subjects who are relatives or students of the investigator, or otherwise in a dependent relationship with the investigator
* Subjects who, in the judgment of the investigator, are unable to provide complete data for the clinical trial due to personal circumstances or other reasons

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Hyehyun Jeong — Asan Medical Center
• Study coordinator: Sangwon Han
• Email: hswon87@amc.seoul.kr
• Phone: +82-2-3010-0657

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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.