CtDNA Based MRD Testing for NAC Monitoring in TNBC

Inclusion Criteria:

1. Have histologically documented TNBC (defined as ER expression ≤10% by IHC, PRexpression≤10% by IHC and HER2 0 or 1+ by IHC or FISH ratio <2 or HER2 gene copynumber of <6).

2. Early-stage breast cancer (stage I-III) and scheduled to undergo NAC treatment withcurative intent.

3. Be informed of the investigational nature of the study and all pertinent aspects ofthe trial.

4. Have the ability to understand and the willingness to sign a written informedconsent 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 theexception 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 ctDNAtesting.

6. Started systemic therapy for their breast cancer.

7. Pregnancy