drugset / Trial / NCT06067503

Biomarkers to Detect Endocrine Therapy Resistance

NCT06067503

Phase 2 Recruiting 8 enrolled University of Wisconsin, Madison
NaSingle-groupOpen-labelDiagnostic

Summary

This pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. Baseline levels and dynamic on-treatment changes in estrogen signaling as measured by FFNP-PET/CT and circulating tumor cell (CTC) liquid biopsy will be correlated with clinical response to endocrine therapy and progression-free survival in the above cohort of patients.

Timeline

Start
2024-04-30
Primary completion
2026-08
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-fluorofuranylnorprogesterone Diagnostic / imaging agent 259 mbq Intravenous