18F‑FES PET/CT to detect distant metastasis in low‑grade ER‑positive stage III breast cancer
A Phase 2, Open-label, Non-randomized, Single Center Study Evaluating 18F-Fluoroestradiol Positron Emission Tomography/Computed Tomography for the Detection of Distant Metastases in Low-grade, Estrogen Receptor-positive Stage III Breast Cancer
This test will see if 18F‑FES PET/CT can better find distant spread in people with low‑grade, estrogen receptor–positive stage III breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07314073 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 19 or older with newly diagnosed, histologically confirmed ER‑positive, grade 1–2 stage III breast cancer who have had recent CT and bone scan and are not yet on systemic therapy.
Not a fit: Patients with high‑grade or ER‑negative tumors, those already receiving systemic therapy, or those whose distant metastases are already identified by conventional imaging are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, 18F‑FES PET/CT could more accurately identify distant and regional metastases in this subgroup, helping tailor surgery and radiotherapy plans.
How similar studies have performed: Prior evidence, including a phase III report showing about 77% sensitivity and 100% specificity, suggests 18F‑FES PET/CT can accurately detect ER‑positive metastatic disease and may outperform standard imaging in low‑grade and lobular cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul
- 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
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.