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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
