Actively Recruiting

Age: 18Years +
FEMALE
NCT07332975

ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

Led by University of Pittsburgh · Updated on 2026-05-01

77

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be 18 years of age or older
  • Cytologically or histologically confirmed invasive breast cancer that is clinical stage I
  • Tumor 2 cm or smaller on imaging
  • Clinical node negative (cN0) and no distant metastasis (cM0)
  • Tumor grade 2 or 3
  • ECOG performance status of 0 to 2
  • Estrogen receptor positive in 0% of cells (ER-negative)
  • HER2-negative status (IHC 2+/FISH-negative or IHC 0 or 1+ with FISH-negative or untested)
  • No prior chemotherapy for breast cancer
  • Fit for chemotherapy and surgery
  • Able to understand and willing to sign informed consent
  • Willing to provide serial blood samples for the study
Not Eligible

You will not qualify if you...

  • History of other invasive cancers within the past 2 years
  • Presence of synchronous, multifocal, or multicentric breast cancers
  • Any medical or social condition that might prevent following the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UPMC Hillman Cancer

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

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Research Team

K

Kelsey Mitch, BSN

CONTACT

L

Lucia M Borrasso, BSN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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