Summary
This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the
clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management
in ER-positive, HER2-negative metastatic breast cancer patients with progressive disease
on first-line standard-of-care hormonal therapy. All patients will undergo a Cerianna
PET/CT scan. The treating physician will complete a standardized questionnaire to
indicate the second-line therapeutic management plan before the scheduled Cerianna
PET/CT. After interpretation of Cerianna PET/CT by local radiologist or nuclear medicine
physician, the treating physician will fill out a similar questionnaire to specify the
final therapeutic decision. The proportion of patients with a change in therapeutic
management plan based on Cerianna PET/CT results will be the primary endpoint. During the
study follow-up period of 18 months, data on standard-of-care imaging,
treatments/procedures received, and clinical outcomes will be collected. Patients will be
asked to complete a health-related quality of life questionnaire at their screening,
6-month, and 18-month visit. Secondary endpoints include visual and quantitative
heterogeneity assessment of tumor Cerianna uptake, and PFS rates at 6 months and 18
months after Cerianna PET/CT, which will be assessed between patients with and without a
change in therapeutic management plan. Maximum duration of follow-up for each patient: 20
months. First patient first visit to last patient last visit: estimated 36 months.