Status:
RECRUITING
Biomarkers to Detect Endocrine Therapy Resistance
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Metastatic Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ther...
Eligibility Criteria
Inclusion
- Willing to provide informed consent
- Individuals at least 18 years of age
- Have biopsy-proven ER/PR-positive (defined as ER ≥1 percent and PR ≥1 percent by IHC) and HER2-negative advanced or metastatic LBC starting new standard of care endocrine therapy
- Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment per treating oncologist
- Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible
- Willing to comply with all study procedures and be available for the duration of the study
- Disease may be measurable by RECIST 1.1 criteria or non-measurable. Lesion size must be at least 1cm. If only bone lesions present, they should be lytic or mixed lytic-sclerotic. If only liver lesions present, patient is not eligible.
Exclusion
- Patients with active brain metastases
- Patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination
- Unable to lie flat during or tolerate PET/CT
- Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
- Presence of liver failure as judged by patient's treating physician
- Individuals who are pregnant, lactating, or planning on becoming pregnant during the study
- Not suitable for study participation due to other reasons at the discretion of the investigators
- Patients with progesterone-receptor negative disease defined as PR \<1 percent by IHC
Key Trial Info
Start Date :
April 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06067503
Start Date
April 30 2024
End Date
August 1 2026
Last Update
April 22 2025
Active Locations (1)
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1
UW Carbone Cancer Center
Madison, Wisconsin, United States, 53792