In this study, positron emission tomography (PET/CT) imaging will be used to evaluate estrogen receptor (ER) activity in sites of metastatic disease using the investigational radiotracer \[18F\]fluoroestradiol (FES).
This study will evaluate \[18F\]FES PET/CT uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy. Imaging will occur prior to starting new therapy. Some patients may also undergo a second FES PET/CT scan at the time of suspected progression of disease to compare for changes in FES uptake measures. This is an observational study in that \[18F\]FES PET/CT will not be used to direct therapy decisions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
6
\[18F\]FES PET/CT scan
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Evaluate [18F]FES PET/CT Uptake
Evaluate \[18F\]FES PET/CT uptake as a predictor of progression free survival in endocrine refractory recurrent or metastatic breast cancer patients starting a new therapy regimen including endocrine targeted therapy
Time frame: 4 years
Correlate [18F]FES Uptake Measures with Standard Immunohistochemistry
Correlate \[18F\]FES uptake measures with standard immunohistochemistry (IHC) (e.g. ER, PR, HER2-neu) and experimental pathology markers available from primary and/or metastatic tissue
Time frame: 4 years
Evaluate the utility of combined [18F]FES PET/CT and FDG PET/CT
Evaluate the utility of combined \[18F\]FES PET/CT and FDG PET/CT in identifying heterogeneity of estrogen receptor expression and functionality in metastatic breast cancer
Time frame: 4 years
Evaluate Overall Survival in Patients
Evaluate overall survival in patients receiving regimens containing endocrine targeted therapy
Time frame: 4 years
Compare FES Uptake Measures at Baseline and Progression
Compare FES uptake measures at baseline and progression in patients receiving additional endocrine targeted therapy
Time frame: 4 years
Correlate FES uptake measures with number of ER+ Circulating Tumor Cells
Correlate FES uptake measures with number of ER+ Circulating Tumor Cells (CTCs) and ratio of ER+ to ER- CTCs
Time frame: 4 years
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