Overview

Test - Retest Reproducibility of 18F Fluoroestradiol (FES) PET

Status:
Withdrawn
Trial end date:
2021-02-20
Target enrollment:
0
Participant gender:
All
Summary
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 and establishes the repeatability of FES PET/CT.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rathan Subramaniam
University of Texas Southwestern Medical Center
Criteria
Inclusion Criteria:

- 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's standard of care;

- A female of child-bearing potential is any woman (regardless of sexual orientation,
having undergone a tubal ligation, or remaining celibate by choice) who meets the
following criteria;

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has
had menses at any time in the preceding 12 consecutive months).

- Medically stable as judged by patient'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 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

- 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

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

- 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 non-measurable 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 PET/CT scan.

Exclusion Criteria:

. Patients not meeting the inclusion criteria.