ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

Recruiting now

Conditions studied: Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT07332975

Run by

University of Pittsburgh

People needed

77

Starts

2026-01-20

Expected to finish

2029-01-20

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be ≥18 years of age
• 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
• 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.
• Must be willing to provide serial blood samples for the study.

You may not qualify if…

• 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.

Where it is running

• UPMC Hillman Cancer — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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