Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
Personalis Inc.
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.
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 bioinfo…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PR expression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio \<2 or HER2 gene copy number of \<6). 2. Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent. 3. Be informed of the investigational nature of the study and all pertinent aspects of the trial. 4. Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines. 5. Be ≥ 18years of age. 6. Patient who are…
Locations (14)
- Arizona OncologyTucson, Arizona
- University of Colorado Cancer CenterAurora, Colorado
- George Washington UniversityWashington D.C., District of Columbia
- Mount Sinai Medical Center of FloridaMiami Beach, Florida
- Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLCSt. Petersburg, Florida
- Illinois Cancer CarePeoria, Illinois