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.
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 Type
OBSERVATIONAL
Enrollment
422
Arizona Oncology
Tucson, Arizona, United States
RECRUITINGUniversity of Colorado Cancer Center
Aurora, Colorado, United States
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
Evaluate the trajectory of changes in MRD to pCR or non pCR in TNBC
Evaluate the trajectory of changes in MRD detected by NeXT Personal CTA during neoadjuvant chemotherapy (NAC) to pathological Complete Response (pCR) or non pCR in stage I-III triple negative breast cancer (TNBC).
Time frame: through study completion, an average of 6 months
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George Washington University
Washington D.C., District of Columbia, United States
RECRUITINGMount Sinai Medical Center of Florida
Miami Beach, Florida, United States
RECRUITINGComprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC
St. Petersburg, Florida, United States
RECRUITINGIllinois Cancer Care
Peoria, Illinois, United States
RECRUITINGLouisiana State University
New Orleans, Louisiana, United States
RECRUITINGTrinity Health-Michigan
Ypsilanti, Michigan, United States
RECRUITINGNebraska Methodist
Omaha, Nebraska, United States
RECRUITINGStony Brook University Cancer Center
Stony Brook, New York, United States
RECRUITING...and 4 more locations