Study of Molecular Residual Disease Testing Using Circulating Tumor DNA to Monitor Neoadjuvant Chemotherapy Response in Early Stage Triple-Negative Breast Cancer

What this Trial Is About

Researchers are investigating the relationship between Molecular Residual Disease MRD detected through circulating tumor DNA and pathological complete response pCR following neoadjuvant chemotherapy NAC in patients with stage I-III triple negative breast cancer TNBC. This observational study aims to improve MRD detection methods and potentially enhance disease outcomes for future patients. The study uses the NeXT Personal Clinical Trial Assay CTA, a patient-specific, tumor-informed test that detects MRD from cell-free DNA in blood plasma. This involves sequencing DNA from tumor and normal samples to create a personalized DNA panel, which is then applied to analyze plasma samples during and after chemotherapy treatment. No interventional treatments are administered as this is an observational study. Participants provide blood samples before and during chemotherapy, and their available biopsy tissue is used for analysis. Researchers will evaluate the correlation between MRD status and pCR over an average of 6 months. The study includes assessments using next generation sequencing and bioinformatics to monitor MRD, with no additional treatments or interventions required. Participation duration and follow-up are aligned with the chemotherapy schedule and study completion timeframe.

CtDNA Based MRD Testing for NAC Monitoring in TNBC