RECRUITING

Biomarkers to Detect Endocrine Therapy Resistance

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Conditions

Metastatic CancerBreast CancerLobular Breast CarcinomaEndocrine Therapy Resistancecirculating tumor cellliquid biopsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Integrating Minimally Invasive Biomarkers of Estrogen Signaling to Detect Endocrine Therapy Resistance in Metastatic Invasive Lobular Breast Cancer

Quick Facts

Study Start:2024-04-30
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06067503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Willing to provide informed consent
  2. 2. Individuals at least 18 years of age
  3. 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. 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. 5. Patients with evaluable bone-only disease that is lytic or mixed lytic-sclerotic are eligible
  6. 6. Willing to comply with all study procedures and be available for the duration of the study
  7. 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.
  1. 1. Patients with active brain metastases
  2. 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. 3. Unable to lie flat during or tolerate PET/CT
  4. 4. Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
  5. 5. Presence of liver failure as judged by patient's treating physician
  6. 6. Individuals who are pregnant, lactating, or planning on becoming pregnant during the study
  7. 7. Not suitable for study participation due to other reasons at the discretion of the investigators
  8. 8. Patients with progesterone-receptor negative disease defined as PR \<1 percent by IHC

Contacts and Locations

Study Contact

Cancer Connect
CONTACT
800-622-8922
clinicaltrials@cancer.wisc.edu

Principal Investigator

Marina Sharifi, MD, PHD
PRINCIPAL_INVESTIGATOR
UW Carbone Cancer Center

Study Locations (Sites)

UW Carbone Cancer Center
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Marina Sharifi, MD, PHD, PRINCIPAL_INVESTIGATOR, UW Carbone Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-30
Study Completion Date2026-01

Study Record Updates

Study Start Date2024-04-30
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • Endocrine Therapy Resistance
  • circulating tumor cell
  • liquid biopsy

Additional Relevant MeSH Terms

  • Metastatic Cancer
  • Breast Cancer
  • Lobular Breast Carcinoma