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Breast CancerDiagnostics and screeningGeneticsCancerWomen's healthDiagnostic test

What this study is

Simplified from ClinicalTrials.gov

Testing a diagnostic plan that combines a blood test (liquid biopsy) with a follow-up tissue biopsy and genetic testing, to see how useful it is for finding ESR1 gene mutations in adults 18 and older with hormone receptor-positive, HER2-negative breast cancer that has spread.

Read the original summary from ClinicalTrials.gov

This is a prospective, single center, single-arm interventional study to evaluate the clinical utility of protocol-mandated diagnostic testing algorithm incorporating liquid biopsy and reflex tissue biopsy NGS for detection of ESR1 mutations in HR+/HER- metastatic breast cancer.

What's being tested

  • FoundationOne® Liquid CDx (F1LCDx)

    Intervention · DIAGNOSTIC TEST

    Blood test that analyzes cancer-related genes from a single blood draw

  • Reflex tissue biopsy

    Intervention · DIAGNOSTIC TEST

    Reflex tissue biopsy using an Next-generation sequencing (NGS) test

Study details

Official title
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of ESR1 Mutations in HR-positive HER2-negative Metastatic Breast Cancer (MBC)
Sponsor
Yale University
Conditions
Breast Cancer · Metastatic Breast Cancer · HR+/HER- Metastatic Breast Cancer
Enrolling
155 people
Starts
2026-11
Est. completion
2031-10
Design
Open-label, single group
Record
View on ClinicalTrials.gov ↗