RecruitingPhase 2NCT06067503

Biomarkers to Detect Endocrine Therapy Resistance

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


Sponsor

University of Wisconsin, Madison

Enrollment

8 participants

Start Date

Apr 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study collects blood samples over time from patients with ER-positive, HER2-negative advanced or metastatic breast cancer to find biological markers (biomarkers) that can predict whether hormone therapy will stop working — a process called endocrine resistance. The goal is to detect resistance earlier and guide future treatment decisions. **You may be eligible if...** - You are 18 or older - You have ER-positive (≥1%), HER2-negative advanced or metastatic breast cancer (locally advanced, or "lobular breast cancer" subtype also eligible) - You are starting a new standard hormone therapy - You have evaluable disease (measurable tumor or bone-only disease) - Your organ function is adequate for systemic treatment **You may NOT be eligible if...** - Your cancer is ER-negative or HER2-positive - You are not starting a new hormone therapy - Your tumors cannot be evaluated by imaging or lab markers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-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.

DEVICELiquid 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

DEVICEPositron 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

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NCT06067503


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