RECRUITING · INTERVENTIONAL · DIAGNOSTIC study · Breast Cancer · Enrollment 100 · Sponsor: UNC Lineberger Comprehensive Cancer Center
Official title: Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
Summary: The purpose of this study is to determine how circulating tumor DNA (ctDNA), a sign of minimal residual disease (MRD), is detectable after surgery in patients with early HR+/HER2- breast cancer that has spread to 1-3 lymph nodes. Researchers aim to understand if ctDNA detection can identify patients at higher risk of recurrence and guide better treatment decisions. A key aspect is the inclusion of a dedicated cohort of African American/Black women, a group underrepresented in molecular residual disease (MRD) research despite experiencing more aggressive breast cancers. This study will correlate ctDNA results with treatment patterns (radiotherapy, systemic therapy) and outcomes (recurrence-free and overall survival) in both non-African American and African American participants.
Conditions: Breast Cancer, Lymph Node Metastasis
Keywords: circulating tumor DNA (ctDNA), minimal residual disease (MRD), African American
Study type: INTERVENTIONAL
Primary purpose: DIAGNOSTIC
Phases: NA
Enrollment: 100 (ESTIMATED)
Status: RECRUITING
Completion: 2027-08 (ESTIMATED)