NCT06230185

CtDNA Based MRD Testing for NAC Monitoring in TNBC

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 422 (estimated)
• Sponsor: Personalis Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• TNBC - Triple-Negative Breast Cancer
• Minimal Residual Disease

Timeline

• Start date: 2023-11-09
• Primary completion: 2025-08-30
• Completion: 2025-12-31
• First posted: 2024-01-30
• Last updated: 2025-01-07

Locations

14 sites across 1 country: United States