Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Patients must be ≥18 years of age
- 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
- ECOG 0-2
- Locally assessed ER+ in 0% of cells.
- Locally assessed HER2-negative (IHC 2+/FISH-negative or IHC 0 or 1+ /either FISH-negative or untested).
- No prior chemotherapy
- Fit for chemotherapy and surgery
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Must be willing to provide serial blood samples for the study.
Exclusion Criteria:
- History of other invasive malignancy in the past 2 years
- Synchronous breast cancers and multifocal/multicentric breast cancers
- Medical condition or social situation that may preclude adherence to the protocol.
