Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
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.
Outcome measures
Primary
Evaluate the correlation of MRD to pCR after NAC in TNBC
Evaluate the correlation of MRD detection by NeXT Personal CTA to pathological Complete Response (pCR) after neoadjuvant chemotherapy (NAC) in stage I-III triple negative breast cancer (TNBC). The pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Time frame: through study completion, an average of 6 months
Secondary
Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC
Time frame: through study completion, an average of 6 months
Eligibility criteria
Study locations (14)
Arizona Oncology
Tucson, Arizona, 85704
University of Colorado Cancer Center
Aurora, Colorado, 80045
George Washington University
Washington D.C., District of Columbia, 20037
Mount Sinai Medical Center of Florida
Miami Beach, Florida, 33140
Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC
St. Petersburg, Florida, 33709
Illinois Cancer Care
Peoria, Illinois, 61615
Louisiana State University
New Orleans, Louisiana, 70112
Trinity Health-Michigan
Ypsilanti, Michigan, 48197
Nebraska Methodist
Omaha, Nebraska, 68114
Stony Brook University Cancer Center
Stony Brook, New York, 11794
Oregon Oncology Specialists
Salem, Oregon, 97301
Cancer Care Associates of York
York, Pennsylvania, 17403
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Cancer Care Northwest
Spokane, Washington, 99202