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Biomarkers of Estrogen Signaling in Metastatic Lobular Breast Cancer
NCT06067503Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- University of Wisconsin–Madison
- Modality
- Small Molecules
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of fluorofuranylnorprogesterone in breast cancer, sponsored by University of Wisconsin–Madison. Primary endpoints: Decreased FFNP uptake on PET/CT at 4 weeks, Decrease in circulating tumor cell estrogen signaling at 4 weeks and 1 more. Started Apr 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Participants with ER/PR+ metastatic lobular breast cancer (LBC)
Participants receive FFNP-PET/CT and liquid biopsies at baseline and 4 weeks after starting new standard of care endocrine therapy.
03
Who it enrols
Adults with biopsy-proven ER/PR-positive, HER2-negative advanced or metastatic lobular breast cancer starting new standard of care endocrine therapy. Excludes patients with active brain metastases or liver-only disease.
04
Endpoints
Primary
Decreased FFNP uptake on PET/CT
Decrease in circulating tumor cell estrogen signaling
Decrease in concentration of Circulating Tumor DNA
Secondary
Progression Free Survival
Correlation coefficients
Adverse Events within 24 hours of FFNP infusion
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