Home › Triple-Negative Breast Cancer › NCT07332975
ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC
RecruitingObservational study
A Proportion of ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC (ARES)
Who can join
Ages 18 and older · Women
Full eligibility criteria
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.
About the study
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.
Sponsor: University of Pittsburgh · Participants: 77 · Started: Jan 20, 2026
Contact the study team
- Kelsey Mitch, BSN · Phone: 4126412357
- Lucia M Borrasso, BSN · Phone: 4126413304
Official record on ClinicalTrials.gov — NCT07332975
Locations in the U.S.
| Pennsylvania | UPMC Hillman Cancer, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.