TheranosticTrials.org

Clinical Trial · NCT07867925

Predicting Endocrine Resistance Using Molecular Imaging and Liquid Biopsy in Metastatic Breast Cancer

Overview

This prospective observational study aims to evaluate the prognostic value of molecular imaging biomarkers derived from baseline \[18F\]FES and \[18F\]FDG PET/CT for progression-free survival in patients with estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer receiving first-line endocrine therapy combined with a CDK4/6 inhibitor. In a subset of patients with available tumor tissue, paired tumor tissue next-generation sequencing (NGS) and circulating tumor DNA (ctDNA) analysis will also be performed to investigate their associations with imaging biomarkers, treatment response, and clinical outcomes.

Sponsor

Asan Medical Center

Contacts

Sangwon Han, Clinical assistant professor (PRINCIPAL_INVESTIGATOR)

Jaeeun Kim (CONTACT)

kje0216@amc.seoul.kr

+82-2-3010-4572

Sangwon Han (CONTACT)

hswon87@amc.seoul.kr

+82-2-3010-0657

ClinicalTrials.gov

NCT07867925

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

FES

Isotope(s):
Target(s):
  • Estrogen Receptor
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Histologically confirmed invasive breast cancer that is ER-positive and HER2-negative by immunohistochemistry.
  • Have undergone or be scheduled to undergo \[18F\]FDG PET/CT before initiation of endocrine therapy combined with a CDK4/6 inhibitor.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Have measurable or clinically evaluable metastatic disease on standard-of-care imaging.
  • Scheduled to initiate first-line systemic endocrine therapy with an aromatase inhibitor in combination with a CDK4/6 inhibitor for metastatic breast cancer within 60 days of screening.

Exclusion

  • Metastatic disease confined exclusively to the liver on imaging.
  • Serious, uncontrolled, and/or unstable medical conditions, including but not limited to congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic kidney disease, or chronic liver disease.
  • Absence of lesions with significant uptake on \[18F\]FDG PET/CT, or inability to quantitatively evaluate major lesions because of lesion location (e.g., brain or other sites with high physiologic uptake), severe motion artifacts, reconstruction errors, or other technical limitations.
  • Pregnancy or breastfeeding. Participants are considered not to be of childbearing potential if they are physiologically postmenopausal (amenorrhea for at least 2 years) or surgically sterile (documented bilateral oophorectomy or hysterectomy). Participants of childbearing potential must have a negative serum or urine pregnancy test within 24 hours before \[18F\]FES administration and must use contraception during the study period.
  • Any personal circumstances or other conditions that, in the investigator's judgment, are likely to prevent complete collection of study data.
  • Previous systemic treatment for metastatic breast cancer, including endocrine therapy, targeted therapy, or anticancer chemotherapy including antibody-drug conjugates (ADCs).
  • Being a relative or student of an investigator or otherwise having a dependent relationship with an investigator.