Biomarkers to Detect Endocrine Therapy Resistance/NCT06067503

Eligible patients: Patients with 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. Additional eligibility criteria can be found here

Description of Trial/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 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.

Why is this study beneficial?/Important? This study is exploring the use of liquid biopsy in addition to imaging for metastatic disease monitoring. This type of PET/CT imaging and liquid biopsy has not previously been studied specifically in a cohort of patients with ILC. 

Principal Investigator: Marina Sharifi, MD, PHD

Trial Location: UW Carbone Cancer Center, Madison, WI 53792

Trial Contact:
Cancer Connect
800-622-8922
clinicaltrials@cancer.wisc.edu 

For more information: https://clinicaltrials.gov/study/NCT06067503?cond=lobular&aggFilters=status:rec&rank=10 

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