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New blood test could spot hidden breast cancer before scans do

NCT ID NCT07069595

Disease control Sponsor: UNC Lineberger Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is for people with a high-risk type of breast cancer (triple-negative) who still have cancer cells left after standard treatment and surgery. Researchers will use a special blood test (ctDNA) to look for tiny traces of cancer DNA that scans might miss. If the test finds cancer, participants will receive an experimental drug called Dato-DXd to try to eliminate it. The goal is to see if this approach can catch and treat recurrence earlier than usual.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Datopotamab deruxtecan (Dato-DXd)
What this could lead to
If successful, this could lead to a way to detect cancer recurrence earlier and treat it with a targeted drug, potentially improving outcomes for high-risk TNBC patients.
What could go wrong
This is a small, early-phase study (Phase II) with only 78 participants, so results may not apply to all patients. The drug Dato-DXd can cause side effects, and the ctDNA test may not always detect recurrence accurately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Written informed consent was obtained to participate in the study, and HIPAA authorization for the release of personal health information. * Participant is willing and able to comply with study procedures based on the judgment of the investigator. * Age ≥ 18 years at the time of consent. * Histological confirmation of TNBC defined by ER/PR \<10%, HER2 0-1+ by IHC or 2+ by IHC and fluorescence in situ hybridization (FISH) negative. * Stage II/III TNBC treated with neoadjuvant systemic therapy AND have residual disease defined as RCB II/III at time of surgery. * Baseline staging scans at the discretion of the treating physician and demonstrate no evidence of metastatic disease. * The participant must have archival diagnostic tissue and/or surgical resection tissue Available. * Participants are willing and able to comply with study procedures based on the judgment of the investigator. Exclusion Criteria: • Participants are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Neoplasm, Residual triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Residual disease Stage II/III Triple negative breast cancer (TNBC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UNC Lineberger Comprehensive Cancer Center

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

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