Biomarkers to Detect Endocrine Therapy Resistance
Recruiting now · Phase 2
Conditions studied: Metastatic Cancer, Breast Cancer, Lobular Breast Carcinoma
In brief
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 facts
- Study ID
- NCT06067503
- Run by
- University of Wisconsin, Madison
- People needed
- 8
- Starts
- 2024-04-30
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UW Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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