Phase II Trial of 4FMFES-PET Combined with FDG-PET for Diagnosis and Management of Advanced Estrogen Receptor-Positive Breast Cancer

What this Trial Is About

Researchers are evaluating a new imaging method called 4FMFES-PET combined with FDG-PET to improve diagnosis and management of advanced estrogen receptor-positive ER breast cancer. ER status is a key factor in guiding treatment choices, but tumors can vary in ER expression over time and across sites. This study aims to assess the full potential of 4FMFES-PET, which has shown better image quality and tumor detection than earlier tracers, in combination with FDG-PET for whole-body, non-invasive ER status evaluation in advanced breast cancer patients. Participants with advanced ER breast cancer will undergo 4FMFES-PET imaging at the start, then again at 6 and 18 months, within 4 weeks of medically prescribed FDG-PET scans. The 4FMFES tracer is given intravenously followed by PET imaging. The study will compare and complement these PET scans with conventional imaging and correlate imaging results with pathology from biopsies and with clinical outcomes like treatment response and progression-free survival. During the study, participants will have multiple PET scans to monitor ER expression and tumor activity over time. Researchers will collect pathological data and track outcomes such as time to recurrence and treatment effects. The main measurements include uptake of 4FMFES on PET scans correlated with tissue markers and clinical progress over 18 to 36 months. This approach aims to better identify patient groups who may benefit from this imaging method to guide their care.

4FMFES-PET Imaging of ER+ Advanced Breast Cancers