Biomarkers to Detect Endocrine Therapy Resistance
Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer
4 other identifiers
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedStudy Start
First participant enrolled
April 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
April 13, 2026
April 1, 2026
2.3 years
September 19, 2023
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy
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.
baseline, 4 weeks
Number of Participants who have a decrease in concentration of Circulating Tumor DNA in response to endocrine therapy
baseline, 4 weeks
Secondary Outcomes (3)
Progression Free Survival (PFS) for 6 months
up to 6 months
Correlation coefficients
up to 6 months
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
Study Arms (1)
Participants with ER/PR+ metastatic lobular breast cancer (LBC)
EXPERIMENTALInterventions
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
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.
Eligibility Criteria
You may qualify if:
- Willing to provide informed consent
- Individuals at least 18 years of age
- 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
- Adequate organ function as indicated by standard laboratory tests (CBC, liver function tests or CMP) allowing for systemic breast cancer treatment per treating oncologist
- Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible
- Willing to comply with all study procedures and be available for the duration of the study
- 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.
You may not qualify if:
- Patients with active brain metastases
- Patients with liver-only disease are not eligible due to high background liver activity related to the radiopharmaceutical's hepatobiliary route of elimination
- Unable to lie flat during or tolerate PET/CT
- Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
- Presence of liver failure as judged by patient's treating physician
- Individuals who are pregnant, lactating, or planning on becoming pregnant during the study
- Not suitable for study participation due to other reasons at the discretion of the investigators
- Patients with progesterone-receptor negative disease defined as PR \<1 percent by IHC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UW Carbone Cancer Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marina Sharifi, MD, PHD
UW Carbone Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2023
First Posted
October 5, 2023
Study Start
April 30, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- up to 7 years after the completion of the primary endpoint
- Access Criteria
- UWCCC Cancer Connect: clinicaltrials@cancer.wisc.edu
Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting the University of Wisconsin Carbone Cancer Center (UWCCC)