drugset / Trial / NCT04174352

FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer

NCT04174352

Phase 0 Recruiting 12 enrolled University of Wisconsin, Madison
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-10-20
Primary completion
2026-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tamoxifen Small molecule 20 mg Oral
Subject Tamoxifen Small molecule 80 mg Oral
Subject Tamoxifen Small molecule 160 mg Oral
Subject Tamoxifen Small molecule 200 mg Oral