Life sciences · Interventional Study
ClinicalTrials.gov · November 2, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07910565). This is a study registration, not published results. Lead sponsor: Yale University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 155 participants (ESTIMATED). Conditions: Breast Cancer, Metastatic Breast Cancer, HR+/HER- Metastatic Breast Cancer. Interventions: DIAGNOSTIC_TEST: FoundationOne® Liquid CDx (F1LCDx); DIAGNOSTIC_TEST: Reflex tissue biopsy. Primary outcome measures: Number of participants with ESR1 mutations detected by reflex tissue NGS , From enrollment through study completion (up to 5 years). Brief 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.