Biomarkers to Detect Endocrine Therapy Resistance

Last updated: April 16, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

2

Condition

Cancer

Breast Cancer

Neoplasm Metastasis

Treatment

Liquid Biopsy

Positron Emission Tomography/Computed Tomography

18F-fluorofuranylnorprogesterone

Clinical Study ID

NCT06067503
2023-1103
Protocol Version 7/7/2023
SMPH/MEDICINE/HEM-ONC
UW23076
Protocol Version 10/2/2023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 byIHC) and HER2-negative advanced or metastatic LBC starting new standard of careendocrine therapy

  4. Adequate organ function as indicated by standard laboratory tests (CBC, liverfunction tests or CMP) allowing for systemic breast cancer treatment per treatingoncologist

  5. Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic areeligible

  6. Willing to comply with all study procedures and be available for the duration of thestudy

  7. Disease may be measurable by RECIST 1.1 criteria or non-measurable. Lesion size mustbe at least 1cm. If only bone lesions present, they should be lytic or mixedlytic-sclerotic. If only liver lesions present, patient is not eligible.

Exclusion

Exclusion Criteria:

  1. Patients with active brain metastases

  2. Patients with liver-only disease are not eligible due to high background liveractivity 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 similarchemical 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 thestudy

  7. Not suitable for study participation due to other reasons at the discretion of theinvestigators

  8. Patients with progesterone-receptor negative disease defined as PR <1 percent by IHC

Study Design

Total Participants: 8
Treatment Group(s): 3
Primary Treatment: Liquid Biopsy
Phase: 2
Study Start date:
April 30, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • UW Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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