Recruiting

CtDNA Based MRD Testing for NAC Monitoring in TNBC

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.

ClinicalTrials.gov IDNCT06230185

PhaseNot Applicable

Enrollment422

SponsorPersonalis Inc.

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

TNBC - Triple-Negative Breast Cancer, Minimal Residual Disease

About this study

Primary outcomes

Evaluate the correlation of MRD to pCR after NAC in TNBC (through study completion, an average of 6 months)

Eligibility information

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 locations

Arizona Oncology, Tucson, Arizona 85704 United States
University of Colorado Cancer Center, Aurora, Colorado 80045 United States
George Washington University, Washington D.C., District of Columbia 20037 United States
Mount Sinai Medical Center of Florida, Miami Beach, Florida 33140 United States
Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC, St. Petersburg, Florida 33709 United States
Illinois Cancer Care, Peoria, Illinois 61615 United States
Louisiana State University, New Orleans, Louisiana 70112 United States
Trinity Health-Michigan, Ypsilanti, Michigan 48197 United States
Nebraska Methodist, Omaha, Nebraska 68114 United States
Stony Brook University Cancer Center, Stony Brook, New York 11794 United States

Showing 10 of 14 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.