RecruitingNot Applicable

ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

United States77 participantsStarted 2026-01-20

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Patients must be ≥18 years of age
✓. Cytologically or histologically confirmed and previously untreated invasive breast cancer that is:
✓. 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.

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.

What they're measuring

ctDNA detection

Timeframe: Up to 2 years

Trial details

NCT IDNCT07332975

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-01-20

Contact for this trial

Kelsey Mitch, BSN

4126412357 adamikka2@upmc.edu

View on ClinicalTrials.gov More Triple Negative Breast Cancer trials