FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04174352
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • ERα+ Breast Cancer
  • ESR1 Gene Mutation

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tamoxifen — DRUG
    estrogen modulator
  • FES PET/CT — DIAGNOSTIC_TEST
    Radiolabeled estrogen \[18F\]-fluoroestradiol (FES) in combination with Positron Emission Tomography / Computed Tomography is a molecular imaging technique for measuring pharmacodynamic effects of endocrine therapy. The injected dose of 18F-FES will be 6 mCi (185 MBq) ± 20% with a specific activity greater than 170 Ci/mmol at the time of injection for an activity dose of 6 mCi. Participant will receive baseline imaging and repeat imaging after 3-4 weeks to evaluate for FES blockade as assigned dose level.

Study Details

Despite broad advancements in endocrine therapy for ERα+ breast cancer, resistance ultimately develops. A common driver of resistance are known ESR1 mutations that lead to constitutively active receptor signaling and transcriptional regulation that is always "turned on" despite the absence of estrogen. Patients with ESR1 mutations are expected to have decreased binding affinity for tamoxifen and thus may be underdosed on standard therapy. \[18F\]-fluoroestradiol Positron Emission Tomography/Computed tomography (FES-PET/CT) imaging is a novel functional imaging technique that can non-invasively measure ERα expression and inhibition in metastatic ERα+ breast cancer. The proposed a pilot study uses FES-PET/CT imaging to measure ERα blockade to determine the optimal dose of tamoxifen in patients with ESR1 mutations.

Key Dates

Start date
Oct 20, 2020
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tamoxifen Dose Levels
    Three participants will be enrolled to each dose level of oral tamoxifen (n = 12) Dose Level 1 = 20 mg daily Dose Level 2 = 80 mg daily Dose Level 3 = 160 mg daily Dose Level 4 = 200 mg daily Tamoxifen should be started within 14 days of the FES-PET/CT scan, at least 24 hours after FES injection. Participants will continue tamoxifen therapy until there is radiologic or clinical evidence of progressive disease or drug intolerance.

Primary Outcome Measure

Rate of FES Blockade at each dose level to determine the Optimal Tamoxifen Dose [ Time Frame: up to 6 weeks to compare baseline and treatment images ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Cancer Connect
[email protected]
800-622-8922
Kari Wisinski, MD (PRINCIPAL_INVESTIGATOR)
Wisconsin Oncology Network (WONIX) sitesMadisonWisconsin53792
Cancer Connect
[email protected]
800-622-8922

Find similar trials in Madison, WI

By research site
University of Wisconsin Carbone Cancer Center· Madison, WIWisconsin Oncology Network (WONIX) sites· Madison, WI

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