Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer

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.

NCT Number	NCT07025785
Lead Sponsor	UNC Lineberger Comprehensive Cancer Center Collaborators: Haystack Oncology, Inc.
Conditions	Breast Cancer, Lymph Node Metastasis
Enrollment	100 participants
Start Date	2025-08-22
Primary Completion	2026-08 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2026-01-15