Diagnostic Testing for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jing Du, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for people with metastatic breast cancer that is hormone receptor positive (HR+) and HER2 negative. Participants must be able to provide blood samples and may need a tissue biopsy if required by the study.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests whether using a liquid biopsy (FoundationOne® Liquid CDx) followed by a tissue biopsy can effectively detect ESR1 gene mutations in this type of breast cancer. All participants receive these diagnostic tests.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with ESR1 mutations in HR+/HER- metastatic breast cancer undergoing tissue biopsy for ctDNA Tumor Fraction (TF) testing using next-generation sequencing (NGS) after an indeterminate negative result in liquid biopsy (F1LCDx).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Foundation Medicine
Industry Sponsor
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