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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

Official record on ClinicalTrials.gov — NCT07332975

Locations in the U.S.

PennsylvaniaUPMC 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.