ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)

This translational biomarker study will collect blood in patients Stage I triple negative breast cancer at diagnosis prior to either neoadjuvant treatment or surgery and then during treatment.

A highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors has been developed. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay employing DNA sequences derived from breast biopsies and/ or surgery specimens. The abundance and molecular characteristics of ctDNA will be evaluated in 77 patients using optimum Simon Stage II statistical design.

Inclusion Criteria:

1. Patients must be ≥18 years of age

2. Cytologically or histologically confirmed and previously untreated invasive breast cancer that is:

   • Clinical stage I
   • ≤2 cm on imaging
   • cN0
   • cM0
   • Grade 2 or Grade 3

3. ECOG 0-2

4. Locally assessed ER+ in 0% of cells.

5. Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).

6. No prior chemotherapy

7. Fit for chemotherapy and surgery

8. Must have the ability to understand and the willingness to sign a written informed consent document.

9. Must be willing to provide serial blood samples for the study.

Exclusion Criteria:

1. History of other invasive malignancy in the past 2 years
2. Synchronous breast cancers and multifocal/multicentric breast cancers
3. Medical condition or social situation that may preclude adherence to the protocol.