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 range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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