Biomarkers to Detect Endocrine Therapy Resistance

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06067503
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • 18F-fluorofuranylnorprogesterone — DRUG
    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.
  • Liquid Biopsy — DEVICE
    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
  • Positron Emission Tomography/Computed Tomography — DEVICE
    FFNP drug in combination with PET/CT scans to image participant

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Participants with ER/PR+ metastatic lobular breast cancer (LBC)

Primary Outcome Measure

Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy [ Time Frame: baseline, 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UW Carbone Cancer CenterMadisonWisconsin53792-

Find similar trials in Madison, WI

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UW Carbone Cancer Center· Madison, WI

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