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TUKYSA under the microscope: how safe is it in everyday use?

NCT ID NCT06873191

Disease control Sponsor: Pfizer 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tracks 600 adults in Korea with advanced HER2-positive breast cancer who are starting TUKYSA for the first time. Researchers will monitor how well the drug works and any side effects in real-world settings, outside of controlled trials. The goal is to confirm the drug's safety and effectiveness as part of a required post-approval review.

What this could mean

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

Active substance
TUKYSA (tucatinib)
What this could lead to
If successful, this study will confirm that TUKYSA works safely in everyday clinical practice, supporting its continued use for advanced HER2+ breast cancer.
What could go wrong
This is an observational study, not a new treatment test. It only monitors existing use, so it won't discover new cures or major breakthroughs. Results may be limited to Korean 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 600 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 study population for this study includes subjects aged 18 years or older who will be monitored for any adverse events during treatment with TUKYSA® Tablets and for 28 days following the cessation of treatment in the Republic of Korea.

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 criterias. 1. Patient who is treated with TUKYSA according to the current TUKYSA label for the approved indication. 2. Patient who is treated with TUKYSA for the first time. 3. Patient who is aged 18 or over. 4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion criterias. 1\. Patients to whom TUKYSA is contraindicated as per the local labeling Note: The summary for any patients who are violated in the inclusion/exclusion criteria (i.e. protocol violation case) will be separately done if collected and described in the separate section of the report.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

HER2-positive locally advanced unresectable Metastatic breast cancer

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.