Study of a Blood Test to Detect Molecular Residual Disease and Predict Recurrence in High-Risk Early Breast Cancer Treated with Neoadjuvant Chemotherapy

What this Trial Is About

Researchers are evaluating a method to detect molecular residual disease MRD in people with high-risk early breast cancer undergoing chemotherapy. This observational study aims to predict cancer recurrence by analyzing circulating tumor DNA ctDNA from blood and tissue samples. Participants will be followed for up to 5.5 years to better understand the presence of tumor DNA after treatment and its relation to cancer outcomes. The study involves collecting blood and tissue samples to perform a ctDNA MRD test. Participants must have a confirmed invasive breast cancer planned for neoadjuvant chemotherapy, with tumors 2.1 cm or larger and certain clinical subtypes or risk factors. Residual tissue from diagnostic biopsies will be used to create personalized ctDNA assays. No experimental treatment is given instead, participants are observed to assess test accuracy and disease recurrence. During the study, participants will provide blood samples totaling 34 cc at research visits and submit available biopsy tissue. Researchers will evaluate tissue sample quality and track distant recurrence-free intervals over six years. Various outcomes such as tumor mutation prevalence, test sensitivity, survival rates, and time to recurrence will be measured. The studys long-term follow-up allows close monitoring of disease status and patient health.

EXActDNA-003 / NSABP B-64: Study of Molecular Residual Disease Detection in Breast Cancer (MRD)