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Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
Sponsor: UNC Lineberger Comprehensive Cancer Center
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-08-22
Completion Date
2027-08
Last Updated
2026-01-15
Healthy Volunteers
Yes
Conditions
Interventions
Circulating tumor DNA
Circulating tumor DNA (ctDNA) is a noninvasive prognostic biomarker for disease monitoring. ). Blood collection for ctDNA testing will be performed at the time of enrollment (prior to initiation of adjuvant therapy), and every three months thereafter.
Locations (1)
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States