A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
University of Pittsburgh
Summary
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Location
- UPMC Hillman CancerPittsburgh, Pennsylvania