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RECRUITING
NCT06067503
PHASE2

Biomarkers to Detect Endocrine Therapy Resistance

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

Official title: Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2024-04-30

Completion Date

2026-08

Last Updated

2025-04-22

Healthy Volunteers

No

Interventions

DRUG

18F-fluorofuranylnorprogesterone

The dose of the investigational imaging agent, FFNP, is approximately 7 millicurie (mCi) (259 megabecquerels (MBq)), IV slow infusion over approximately two minutes followed by saline flush.

DEVICE

Liquid Biopsy

20ml of whole blood will be collected into two Ethylenediaminetetraacetic acid (EDTA) tubes at each timepoint, CTCs are isolated using the microfluidic Versatile Exclusion-based Rare Sample Analysis (VERSA) platform that integrates CTC capture with RNA extraction on a single chip using Exclusion-Based Sample Preparation (ESP) technology

DEVICE

Positron Emission Tomography/Computed Tomography

FFNP drug in combination with PET/CT scans to image participant

Locations (1)

UW Carbone Cancer Center

Madison, Wisconsin, United States