CtDNA Based MRD Testing for NAC Monitoring in TNBC

Prior treatment

• Receiving concurrent anti-neoplastic therapy for another malignancy.
• Blood transfusion within two weeks before collection of blood for central ctDNA testing.

Other illness

• 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.
• Started systemic therapy for their breast cancer.

Other

• Pregnancy

• 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.