Molecular Residual Disease Assessment in a Representative Diverse Population of Patients With Early-stage Breast Cancer
Recruiting · NCT07025785 · Interventional (participants receive a specific treatment) · Lead sponsor: UNC Lineberger Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at time of consent.
- Subject must have had surgical intervention and must have sufficient archival specimens from either the primary tumor or a lymph node for ctDNA assay development, as specified in the lab manual.
Exclusion criteria
- Subjects must not have had prior neoadjuvant therapy.
- Evidence of metastatic disease in imaging.
- N1 mic or isolated tumor cells in the lymph nodes
Where it is running
1 location listed across 1 US state.
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill, North Carolina, United States