NCT07332975Recruiting
ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
University of Pittsburgh
Start Date
1/20/2026
Completion Date
1/20/2029
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.
Detailed 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 Criteria
Age Range: 18 years to No maximum
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.
Conditions
Triple Negative Breast Cancer
Locations
UPMC Hillman Cancer
Pittsburgh, Pennsylvania 15232
United States