Estrogen Receptor Positive Breast Cancer Clinical Trial
Official title:
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE: Functional Precision Oncology for Metastatic Breast Cancer Feasibility Trial
This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional precision oncology trials. The unique ability of FES-PET/CT to show absence of functional estrogen receptors throughout the entire body may improve confidence among research oncologists that an ER+ metastatic breast cancer patient is truly refractory to hormonal therapies which is a critical determination in the study design of the FORESEE trial.
| Status | Recruiting |
| Enrollment | 6 |
| Est. completion date | April 30, 2026 |
| Est. primary completion date | April 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Adults aged 18 years or greater. - All patients or legal guardians are willing and able to sign written informed consent and HIPAA authorization in accordance with local and institutional guidelines. - Enrolled on the FORESEE trial. - Biopsy proven estrogen receptor positive breast cancer. - Patient deemed refractory to all combinations of hormonal therapies by FORESEE trial investigators. Exclusion Criteria: - Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion. - Patients who require monitored anesthesia for PET/CT scanning. - Patients who are too claustrophobic to undergo PET/CT scanning. - Patients who are pregnant or currently breast feeding. - Any patient that is medically unstable defined as a patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at the time of imaging. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| University of Utah |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients on the FORESEE trial refractory to all combinatorial hormonal therapies that are recruited and imaged with FES-PET/CT prior to switching to non-hormonal therapeutic agents | establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials | 12 weeks | |
| Secondary | Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy | assess FES-PET/CT concordance with ER status from patient-derived organoid models and concordance between FES-PET/CT imaging and patient-derived organoid drug profiling results for predicting response to hormonal therapies | 12 weeks | |
| Secondary | Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models | assess FES-PET/CT concordance with ER status from patient-derived organoid models and concordance between FES-PET/CT imaging and patient-derived organoid drug profiling results for predicting response to hormonal therapies | 12 weeks |
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