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ctDNA Based MRD Testing for NAC Monitoring in TNBC — B-STRONGER-I  

Minimal Residual Disease Clinical Trial

Official title:
Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients With Early Stage TNBC-Phase I (B-STRONGER-I)

Clinical Trial Summary

A prospective, multicenter, observational study to evaluate the correlation of Molecular Residual Disease (MRD) detection using circulating tumor DNA guided test to pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). Results from this study aim to improve MRD detection and disease outcomes for future patients.

Clinical Trial Description

NeXT Personal CTA (Clinical Trial Assay) is a patient-specific, tumor-informed device which allows for detection of MRD from cfDNA. By using next generation sequencing technology, whole genome sequencing (WGS) is conducted from DNA derived from patient tumor and normal samples. A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters. The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples. The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06230185
Study type Observational
Source Personalis Inc.
Contact Ruth Stone
Phone 518 669 9232
Email restone@criteriuminc.com
Status Recruiting
Phase
Start date November 9, 2023
Completion date December 31, 2025
View Details
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