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Could a simple blood test tell some breast cancer patients It's safe to stop treatment?

NCT ID NCT06663787

Knowledge-focused Sponsor: Nagoya City University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 HER2-positive metastatic breast cancer who have had a lasting response (complete or partial remission for over 2 years) on anti-HER2 therapy. Researchers will use a personalized blood test called Signatera to look for tiny amounts of cancer DNA. The goal is to see if this test can help guide future decisions about continuing or stopping treatment.

What this could mean

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

Active substance
Trastuzumab (Herceptin) and other anti-HER2 drugs
What this could lead to
If successful, this could help doctors decide whether some patients can safely stop or reduce their anti-HER2 therapy, potentially reducing side effects and treatment burden.
What could go wrong
This is a small, observational study (50 people) that only measures DNA in the blood—it does not test whether changing treatment is safe. The results may not apply to all patients.

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.

Participants

About 50 people

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

Started

Apr 2024

Expected to finish

Dec 2026

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.

Who is studied

The eligibility criteria for this study include patients who have been diagnosed with histologically confirmed invasive breast cancer and unresectable HER2-positive breast cancer. Eligible cases are those in which drug therapy, including anti-HER2 therapy, was initiated between January 1, 2000, and December 31, 2021. Additionally, patients must have maintained a partial or complete response to drug therapy, including anti-HER2 therapy, for more than two years. Finally, the study is limited to female patients aged 20 years or older.

Ages

20 years and older

Sex

Female participants only

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: * HER2 + metastatic breast cancer * Pre / post menopausal * Previously treated with anti-HER2 therapy * Continuing CR or PR for more than 2 year Exclusion Criteria: * Patients who were deemed inappropriate as research subjects based on the physician's judgment, such as those possibly receiving inappropriate treatment.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma Her2-receptor negative breast cancer Neoplasm Metastasis Neoplasm, Residual

As listed by the trial registrant

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

Breast cancer, metastatic HER2 + breast cancer

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 4678601, Japan

  • Nagoya City University

    Nagoya, Aichi-ken, 4678601, Japan

  • Natera

    San Carlos, Texas, 94070, United States

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Tokyo, Tokyo, 135-8550, Japan

More trials for these conditions

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