Assessment of Functional Status of Estrogen Receptors in Breast Cancer by Positron Emission Tomography
Status:
Completed
Trial end date:
2019-01-03
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the uptake of a radioactive tracer
21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione (FFNP)
uptake, which binds to breast cancer progesterone receptors (PgRs) on a PET/CT scan before
and after administration of estradiol for one day (estrogen challenge) to determine if the
change in uptake is a predictor of response to endocrine therapy (ET) in patients with
hormone-sensitive estrogen receptor positive (ER+), human epidermal growth factor receptor
2-negative (HER2-) breast cancer. Estradiol is the most potent of the naturally occurring
estrogens, and can be administered to treat menopausal symptoms and also sometimes to treat
metastatic breast cancer. The investigators propose to study patients with biopsy-proven
newly diagnosed, locally advanced, metastatic, or recurrent breast cancer who are going to be
treated with endocrine therapy (ET) (tamoxifen,aromatase inhibitors or fulvestrant as
standard of care therapy.
Subjects will undergo a total of two FFNP-PET/CT scans; one before and a second one
immediately following the one day estradiol challenge before the start of standard of care
ET. The estradiol challenge will consist of administering a total of 6 mg of estradiol orally
(three doses of 2 mg each) given at approximately 8 hour intervals and over a 24 hour period.