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CtDNA Based MRD Testing for NAC Monitoring in TNBC

NCT06230185 · Personalis Inc.
In plain English

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Official title
Breast Cancer-Minimal/Molecular Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I (B-STRONGER-I)
About this study
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.
Eligibility criteria
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 scheduled to start NAC. 7. Be willing to provide blood samples before and during treatment. 8. Have available biopsy tissue. Exclusion Criteria: 1. Receiving concurrent anti-neoplastic therapy for another malignancy. 2. Stage IV disease. 3. Current or history of another primary cancer within 5 years of study entry, with the exception of basal or squamous cell skin cancer, or non-invasive malignancy. 4. History of allogeneic bone marrow or organ transplant. 5. Blood transfusion within two weeks before collection of blood for central ctDNA testing. 6. Started systemic therapy for their breast cancer. 7. Pregnancy
Study design
Enrollment target: 422 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-11-09
Estimated completion: 2025-12-31
Last updated: 2025-01-07
Primary outcomes
  • Evaluate the correlation of MRD to pCR after NAC in TNBC (through study completion, an average of 6 months)
Sponsor
Personalis Inc. · industry
Contacts & investigators
ContactSoumya Chappidi · contact · schappidi@criteriuminc.com · 484-704-2599
ContactJulee Hartwell · contact · jhartwell@criteriuminc.com · 607-651-6273
InvestigatorPavani Chalasani · principal_investigator, George Washington University
All locations (14)
Arizona OncologyRecruiting
Tucson, Arizona, United States
University of Colorado Cancer CenterRecruiting
Aurora, Colorado, United States
George Washington UniversityRecruiting
Washington D.C., District of Columbia, United States
Mount Sinai Medical Center of FloridaRecruiting
Miami Beach, Florida, United States
Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLCRecruiting
St. Petersburg, Florida, United States
Illinois Cancer CareRecruiting
Peoria, Illinois, United States
Louisiana State UniversityRecruiting
New Orleans, Louisiana, United States
Trinity Health-MichiganRecruiting
Ypsilanti, Michigan, United States
Nebraska MethodistRecruiting
Omaha, Nebraska, United States
Stony Brook University Cancer CenterRecruiting
Stony Brook, New York, United States
Oregon Oncology SpecialistsRecruiting
Salem, Oregon, United States
Cancer Care Associates of YorkRecruiting
York, Pennsylvania, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
Cancer Care NorthwestRecruiting
Spokane, Washington, United States
CtDNA Based MRD Testing for NAC Monitoring in TNBC · TrialPath