[18F]FES PET/CT in Endocrine Refractory Breast Cancer (NCT02409316) | Clinical Trial Compass
TerminatedPhase 2
[18F]FES PET/CT in Endocrine Refractory Breast Cancer
United States6 participantsStarted 2015-10-15
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 18 years of age
. Recurrent or metastatic cancer that is of known or suspected breast origin - may be biopsy proven or identified on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT)
. History of ER+ pathology (ER+ may be confirmed from surgery or biopsy of primary breast cancer or lymph nodes, and/or surgery or biopsy of a metastatic site, metastatic biopsy is not required)
. At least one site of disease outside of the liver that is seen on standard imaging (e.g. CT, bone scan, MRI, FDG PET/CT); patients with measurable or nonmeasurable disease are allowed.
. History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening
. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
Exclusion criteria
. Females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential.
. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — can you find out why it was stopped, and whether that affects how useful the imaging results from it might be for guiding my care?
2Since this study was testing [18F]FES PET/CT scanning to measure estrogen receptor activity in metastatic breast cancer, is this type of scan available to me outside of a clinical trial, and could it give us useful information about my specific tumors?
3Because this was a Phase 2 trial that was terminated, the evidence on how well [18F]FES PET/CT predicts treatment response is still limited — are there other completed studies or standard imaging approaches we should consider instead?
4My cancer is described as estrogen receptor positive and endocrine refractory, meaning hormone therapy has stopped working — how would a functional estrogen receptor scan like this one potentially change the treatment decisions you'd make for me?
5Are there currently any other active trials using [18F]FES PET/CT or similar imaging for hormone-resistant metastatic breast cancer that might be worth looking into as an alternative to this terminated study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
. History of HER2/neu positive cancer (IHC 3+ and/or FISH positive) as assessed by medical record review at screening