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Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of ESR1 Mutations in HR+/HER2- Metastatic Breast Cancer (MBC)
Sponsor: Yale University
Summary
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
155
Start Date
2026-11
Completion Date
2031-10
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
FoundationOne® Liquid CDx (F1LCDx)
Blood test that analyzes cancer-related genes from a single blood draw
Reflex tissue biopsy
Reflex tissue biopsy using an Next-generation sequencing (NGS) test
Locations (1)
Yale New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States