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CtDNA Based MRD Testing for NAC Monitoring in TNBC
Trial Status: active
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.
Inclusion Criteria
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.
Exclusion Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06230185.
