The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomarkers to Detect Endocrine Therapy Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06067503
Recruitment Status : Recruiting
First Posted : October 5, 2023
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Metastatic Cancer Breast Cancer Lobular Breast Carcinoma Drug: 18F-fluorofuranylnorprogesterone Device: Liquid Biopsy Device: Positron Emission Tomography/Computed Tomography Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : April 30, 2024
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Circulating Tumor Cells (CTC)

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants who have decreased FFNP uptake on PET/CT in response to endocrine therapy [ Time Frame: baseline, 4 weeks ]
  2. Number of Participants who have decrease in circulating tumor cell estrogen signaling in response to endocrine therapy [ Time Frame: 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 [ Time Frame: baseline, 4 weeks ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) for 6 months [ Time Frame: up to 6 months ]
  2. Correlation coefficients [ Time Frame: 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 [ Time Frame: a 24 hour period up to 7 days pre-treatment, a 24 hour period 4 weeks after the first infusion ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06067503


Contacts
Layout table for location contacts
Contact: Cancer Connect 800-622-8922 clinicaltrials@cancer.wisc.edu

Locations
Layout table for location information
United States, Wisconsin
UW Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Marina Sharifi, MD, PHD UW Carbone Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT06067503    
Other Study ID Numbers: 2023-1103
Protocol Version 10/2/2023 ( Other Identifier: UW Madison )
SMPH/MEDICINE/HEM-ONC ( Other Identifier: UW Madison )
UW23076 ( Other Identifier: OnCore ID )
First Posted: October 5, 2023    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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)
Time Frame: up to 7 years after the completion of the primary endpoint
Access Criteria: UWCCC Cancer Connect: clinicaltrials@cancer.wisc.edu

Layout table for additional information
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:
Layout table for MeSH terms
Breast Neoplasms
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary