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NOT YET RECRUITING
NCT07910565
NA

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

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

FoundationOne® Liquid CDx (F1LCDx)

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

DIAGNOSTIC_TEST

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