New imaging technique tracks breast cancer treatment response in real time
NCT ID NCT04692103
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tests a special PET scan (FES) that tracks estrogen receptors in breast cancer tumors. Researchers want to see if changes in scan results before, during, and after hormone therapy can show how well the treatment is working. The study involves adults with estrogen receptor-positive breast cancer that is new, has returned, or spread. Only 2 participants were enrolled, so results are very limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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2 people
The number who actually took part.
- Started
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Jul 2021
- Expected to finish
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Apr 2041
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer * Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease. * At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging. * Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES. * Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist. Selected treatments may be part of experimental treatment protocols for which the patient would be separately consented. * Patients must be willing to undergo serial imaging procedures. * Patients must agree to allow access to clinical records regarding response to treatment and long term follow up. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * An inability to lie still for the tests * Individuals weighing more than 300 lb. (this is the weight limit of the scanner table) * Pregnant or lactating. Women of childbearing potential with either a positive or no pregnancy test at baseline are excluded. * Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication). * Use of tamoxifen, faslodex, DES or any other ER blocking agent \< 6 weeks or chemotherapy \< 3 weeks prior to imaging scan. * Uncontrolled diabetes mellitus (fasting glucose \> 200 mg/dL) * Adult patients who require monitored anesthesia for PET scanning.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
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Other studies related to the condition(s) this trial covers.
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