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 study aims to evaluate the detection rate of distant metastases using \[18F\]FES PET/CT in patients with low-grade, ER-positive stage III breast cancer.
• Male or female patients aged ≥19 years, regardless of race/ethnicity
• Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation.
• Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer
• Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system
• 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
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2