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Observational Study for Stage I Triple Negative Breast Cancer

This study is looking at how a special blood test, called ctDNA detection, can help understand triple negative breast cancer (TNBC) in patients with early-stage disease. Researchers will collect blood samples from about 77 women with Stage I TNBC (cancer that is small and hasn't spread to lymph nodes) before and during their treatment. The study aims to see if this highly sensitive blood test, which looks for tiny bits of cancer DNA (circulating tumor DNA or ctDNA), can be detected. You may be eligible if you are at least 18 years old, have newly diagnosed Stage I TNBC that is Grade 2 or 3, and have a good performance status (ECOG 0-2). The main goal is to see if ctDNA can be found in your blood for up to 2 years.

Study design
This is an observational study involving about 77 participants. It is not testing a new treatment, but rather observing a biomarker.
What's involved
You would provide blood samples at diagnosis and during treatment. The specific number of visits or duration of sample collection is not detailed.
Compensation
Not stated in the trial record.
Follow-up
The study will look for ctDNA detection for up to 2 years.

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NCT07332975

ctDNA Positive Patients Diagnosed With cT1bN0 and cT1cN0 TNBC

Recruiting
Not specifiedAges 18+Observational
University of Pittsburgh
~77 participants
Updated 2026-05-01 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ctDNA detection
Measured over Up to 2 years

Conditions

Triple Negative Breast Cancer

Explore related trials

Breast CarcinomaCirculating Tumor-Derived DNA Negative

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Marija Balic, MD · PRINCIPAL_INVESTIGATOR · UPMC Hillman Cancer Center

Who to contact

Kelsey Mitch, BSN
[email protected]
4126412357
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • ctDNA detectionUp to 2 years

    Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. This assay has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.