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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8
The dose of the investigational imaging agent, FFNP, is approximately 7 millicurie (mCi) (259 megabecquerels (MBq)), IV slow infusion over approximately two minutes followed by saline flush.
20ml of whole blood will be collected into two Ethylenediaminetetraacetic acid (EDTA) tubes at each timepoint, CTCs are isolated using the microfluidic Versatile Exclusion-based Rare Sample Analysis (VERSA) platform that integrates CTC capture with RNA extraction on a single chip using Exclusion-Based Sample Preparation (ESP) technology
FFNP drug in combination with PET/CT scans to image participant
UW Carbone Cancer Center
Madison, Wisconsin, United States
RECRUITINGNumber of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy
Time frame: baseline, 4 weeks
Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy
Baseline level and on-treatment CTC ESR1 and estrogen regulated gene expression will be evaluated as well as endocrine-resistance associated mutations including ESR1 (though rare in this patient population) and PGR.
Time frame: baseline, 4 weeks
Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy
Time frame: baseline, 4 weeks
Progression Free Survival (PFS) for 6 months
Time frame: up to 6 months
Correlation coefficients
Correlate baseline levels and dynamic on treatment changes in estrogen signaling as measured by FFNP-PET/CT and CTC liquid biopsy with clinical response to endocrine therapy and progression-free survival in patients with ER/PR+ metastatic LBC.
Time frame: up to 6 months
Adverse Events within 24 hours of FFNP infusion
Time frame: a 24 hour period up to 7 days pre-treatment, a 24 hour period 4 weeks after the first infusion
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