Estrogen Receptor Positive Breast Cancer
Conditions
Brief summary
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.
Interventions
\[18F\]Fluoroestradiol (FES) PET/CT
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This is a companion imaging study to IRB # 131027 FORESEE: Functional precision oncology for metastatic breast cancer: a feasibility trial. This companion imaging study will obtain \[18F\]Fluoroestradiol (FES)-PET/CT imaging of breast cancer patients refractory to all combinatorial hormonal therapies enrolled in the FORESEE trial and correlate the FES-PET/CT results with data from FORESEE including estrogen receptor (ER) status and drug profiling results from patient-derived organoid models.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks | establish proof-of-concept to inform use of FES-PET/CT in future larger precision oncology trials |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of concordance between FES-PET/CT imaging (positive or negative uptake) and ER status from tumor biopsy | 12 weeks | 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 |
| Rate of concordance between positive FES-PET/CT scan and response to hormonal therapies from drug profiling results using patient-derived organoid models | 12 weeks | 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 |
Countries
United States
Outcome results
None listed