Test x Retest Reproducibility of 18F Fluoroestradiol (FES) PET and Predictive Measure for Endocrine Therapy Response in Patients with Newly Diagnosed Metastatic Breast Cancer

Study ID
STU 032016-021

Study Sites

  • Clements University Hospital

Ayobami Odu

Principal Investigator
Rathan Subramaniam, M.D., Ph.D.


This study will formally address the hypothesis that FeS-PeT/CT measurement of eR expression predicts clinical benefit of first-line endocrine therapy in newly diagnosed eR+ metastatic breast cancer patients.

Participant Eligibility

* Patients must be over 18 years old and capable and willing to provide informed consent

* Patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to PET/CT
imaging per institution[Single Quote]s standard of care

* Medically stable as judged by patient[Single Quote]s physician

* Life expectancy must be estimated at > 6 months

* Patients must have an ECOG performance status of 0-3(restricted to ECOG PS 0-2 if age >70 years)

* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar
chemical or biologic composition to FES are not eligible

* Patients with liver failure are NOT eligible

* Patient must NOT be breast-feeding

* Histologically confirmed metastatic breast cancer

* Histologically confirmed ER+ breast cancer either from a metastatic biopsy or from a primary breast tumor with imaging evidence of metastatic disease. The pathology report and either (1) tumor tissue (blocks or unstained slides) or (2) a photomicrograph of the ER IHC slide from at least one site of metastatic disease and/or from primary breast cancer must be available for review and analysis

* Patients with human epidermal growth factor-2 positive (HER2+) metastatic tumors are NOT eligible

* No prior endocrine therapy for metastatic disease is allowed (i.e. must be first-line endocrine therapy for metastatic disease). However, a history of adjuvant endocrine therapy is allowed, as long as the date of diagnosis of metastatic disease is > 2
years following initiation of adjuvant endocrine therapy. Patients who develop metastatic disease while still receiving adjuvant endocrine therapy must have a change in the type of endocrine agent used for subsequent metastatic disease
treatment. Patients on blocking adjuvant therapy (with a blocking agent such as toremifene or tamoxifen) must be off the agents for a minimum of 60 days to allow for adequate uptake of FES

* Postmenopausal women, men, or premenopausal women for whom endocrine therapy (tamoxifen, aromatase inhibitor (AI) with or without ovarian suppression or fulvestrant), with or without a CDK4/6 inhibitor is planned after FES-PET/CT is completed

* Disease may be measurable (by RECIST 1.1 criteria) or nonmeasurable but must be present in at least one non-liver site,
1.5 cm or greater and visualized on PET/CT with [18F]- fluorodeoxyglucose (FDG). Patients with effusion only
disease or disease only in the liver are not eligible for the study

* Patient must be able to lie still for a 20 to 30 minute for whole body PET/CT scan