CtDNA Based MRD Testing for NAC Monitoring in TNBC

Recruiting now

Conditions studied: TNBC - Triple-Negative Breast Cancer, Minimal Residual Disease

In brief

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.

Key facts

Study ID

NCT06230185

Run by

Personalis Inc.

People needed

422

Starts

2023-11-09

Expected to finish

2025-12-31

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment with curative intent.
• Be informed of the investigational nature of the study and all pertinent aspects of the trial.
• Have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines.
• Be ≥ 18years of age.
• Patient who are scheduled to start NAC.
• Be willing to provide blood samples before and during treatment.
• Have available biopsy tissue.

You may not qualify if…

• Receiving concurrent anti-neoplastic therapy for another malignancy.
• Stage IV disease.
• 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.
• History of allogeneic bone marrow or organ transplant.
• Blood transfusion within two weeks before collection of blood for central ctDNA testing.
• Started systemic therapy for their breast cancer.
• Pregnancy

Where it is running

• Arizona Oncology — Tucson, Arizona, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• George Washington University — Washington D.C., District of Columbia, United States (enrolling)
• Mount Sinai Medical Center of Florida — Miami Beach, Florida, United States (enrolling)
• Comprehensive Hematology Oncology (ONare Alliance, LLC / Exigent Research, LLC — St. Petersburg, Florida, United States (enrolling)
• Illinois Cancer Care — Peoria, Illinois, United States (enrolling)
• Louisiana State University — New Orleans, Louisiana, United States (enrolling)
• Trinity Health-Michigan — Ypsilanti, Michigan, United States (enrolling)
• Nebraska Methodist — Omaha, Nebraska, United States (enrolling)
• Stony Brook University Cancer Center — Stony Brook, New York, United States (enrolling)
• Oregon Oncology Specialists — Salem, Oregon, United States (enrolling)
• Cancer Care Associates of York — York, Pennsylvania, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Cancer Care Northwest — Spokane, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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