Actively Recruiting
Biomarkers to Detect Endocrine Therapy Resistance
Led by University of Wisconsin, Madison · Updated on 2026-04-13
8
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biomarkers to Detect Endocrine Therapy Resistance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide informed consent
- At least 18 years of age
- Biopsy-proven ER/PR-positive (ER 61% and PR 61% by IHC) and HER2-negative advanced or metastatic lobular breast cancer starting new standard endocrine therapy
- Adequate organ function based on standard lab tests allowing systemic breast cancer treatment
- Evaluable bone-only disease that is lytic or mixed lytic-sclerotic is allowed
- Willing to comply with all study procedures and available for the study duration
- Disease may be measurable by RECIST 1.1 or non-measurable; lesions must be at least 1 cm; liver-only lesions are not eligible
You will not qualify if you...
- Active brain metastases
- Liver-only disease
- Unable to lie flat or tolerate PET/CT
- History of allergic reaction to compounds similar to FFNP
- Presence of liver failure as judged by treating physician
- Pregnant, lactating, or planning pregnancy during the study
- Unsuitable for study due to other reasons per investigators
- Progesterone-receptor negative disease (PR <1% by IHC)
AI-Screening
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Trial Site Locations
Total: 1 location
1
UW Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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