Biomarkers to Detect Endocrine Therapy Resistance

Trial Title: Biomarkers to Detect Endocrine Therapy Resistance

NCT ID: NCT06067503

Condition: Metastatic Cancer
Breast Cancer
Lobular Breast Carcinoma

Conditions: Official terms:
Breast Neoplasms
Carcinoma, Lobular

Conditions: Keywords:
Endocrine Therapy Resistance
circulating tumor cell
liquid biopsy

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 18F-fluorofuranylnorprogesterone
Description: 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.
Arm group label: Participants with ER/PR+ metastatic lobular breast cancer (LBC)

Other name: FFNP

Intervention type: Device
Intervention name: Liquid Biopsy
Description: 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
Arm group label: Participants with ER/PR+ metastatic lobular breast cancer (LBC)

Other name: Circulating Tumor Cells (CTC)

Intervention type: Device
Intervention name: Positron Emission Tomography/Computed Tomography
Description: FFNP drug in combination with PET/CT scans to image participant
Arm group label: Participants with ER/PR+ metastatic lobular breast cancer (LBC)

Other name: PET/CT

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Willing to provide informed consent 2. Individuals at least 18 years of age 3. 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 4. Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment per treating oncologist 5. Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible 6. Willing to comply with all study procedures and be available for the duration of the study 7. 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 Criteria: 1. Patients with active brain metastases 2. Patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination 3. Unable to lie flat during or tolerate PET/CT 4. Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP 5. Presence of liver failure as judged by patient's treating physician 6. Individuals who are pregnant, lactating, or planning on becoming pregnant during the study 7. Not suitable for study participation due to other reasons at the discretion of the investigators 8. Patients with progesterone-receptor negative disease defined as PR <1 percent by IHC

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UW Carbone Cancer Center

Address:
City: Madison
Zip: 53792
Country: United States

Status: Recruiting

Start date: April 30, 2024

Completion date: January 2026

Lead sponsor:
Agency: University of Wisconsin, Madison
Agency class: Other

Source: University of Wisconsin, Madison

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06067503