Assessment of Circulating Tumor DNA to Detect Minimal Residual Disease in Early-stage Breast Cancer Patients Including a Diverse Group of African American Women with Positive Lymph Nodes

What this Trial Is About

Researchers are studying early-stage hormone receptor-positivehuman epidermal growth factor receptor 2-negative HRHER2- breast cancer patients who have cancer spread to 1-3 lymph nodes. The study aims to detect circulating tumor DNA ctDNA after surgery as a sign of minimal residual disease MRD to identify patients at higher risk of cancer recurrence and to guide treatment decisions. A special focus is on African AmericanBlack women, who are underrepresented in MRD research despite facing more aggressive breast cancers. The study will analyze how ctDNA detection relates to treatment choices and patient outcomes in both Black and non-Black participants. Participants include two groups 50 African American and 50 non-African American patients with early breast cancer involving 1-3 lymph nodes. Blood samples will be collected at enrollment before additional therapy starts and every three months afterward to test for ctDNA. Tumor tissue collected during surgery will be used for genetic analysis. Researchers will monitor ctDNA levels without sharing results with treating doctors and will study how ctDNA relates to treatments like radiotherapy and systemic therapy as well as cancer recurrence. During the study, participants will provide blood samples regularly for ctDNA testing. Researchers will collect tumor tissue from surgery and track treatment patterns and patient outcomes over time. The main measurement is the number of patients with positive ctDNA after surgery. The study will help understand ctDNA prevalence and its potential to guide therapy in this patient population. Total participation duration varies, with follow-up visits every three months for blood collection to monitor disease status.

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