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Biomarkers to Detect Endocrine Therapy Resistance

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Recruiting
CT.gov ID
NCT06067503
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants with ER/PR+ metastatic lobular breast cancer (LBC)

Drug: 18F-fluorofuranylnorprogesterone
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.
Other Names:
  • FFNP

    • Device: Liquid Biopsy
    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
    Other Names:
  • Circulating Tumor Cells (CTC)

    • Device: Positron Emission Tomography/Computed Tomography
    FFNP drug in combination with PET/CT scans to image participant
    Other Names:
  • PET/CT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy [baseline, 4 weeks]

    2. Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy [baseline, 4 weeks]

      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.

    3. Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy [baseline, 4 weeks]

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) for 6 months [up to 6 months]

    2. Correlation coefficients [up to 6 months]

      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.

    3. Adverse Events within 24 hours of FFNP infusion [a 24 hour period up to 7 days pre-treatment, a 24 hour period 4 weeks after the first infusion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UW Carbone Cancer Center Madison Wisconsin United States 53792

    Sponsors and Collaborators

    • University of Wisconsin, Madison

    Investigators

    • Principal Investigator: Marina Sharifi, MD, PHD, UW Carbone Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT06067503
    Other Study ID Numbers:
    • 2023-1103
    • Protocol Version 10/2/2023
    • SMPH/MEDICINE/HEM-ONC
    • UW23076
    First Posted:
    Oct 5, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of Wisconsin, Madison
    Endocrine Therapy Resistance
    circulating tumor cell
    liquid biopsy
    Additional relevant MeSH terms:
    Breast Neoplasms
    Carcinoma, Lobular

    Study Results

    No Results Posted as of Oct 12, 2023