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Real-World study tracks tucatinib combo for tough breast cancer

NCT ID NCT05253911

Disease control Sponsor: iOMEDICO AG 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well the drug tucatinib (Tukysa) works in everyday medical practice for people with advanced HER2-positive breast cancer who had already tried at least two other treatments. Researchers tracked 49 adults in Germany and Austria to see how their quality of life changed and how long it took for their cancer to worsen. The goal was to understand the real-world benefits of adding tucatinib to standard therapy.

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

49 people

The number who actually took part.

Started

May 2022

Finished

Jun 2025

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

Adult patients with locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been previously treated with at least two prior anti-HER2 treatment regimens and with decision for treatment with tucatinib (TUKYSA®) in combination with trastuzumab and capecitabine.

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: * Aged 18 years or older. * Histologically confirmed HER2+ breast cancer with HER2 positivity defined as a 3+ score by immunohistochemistry (IHC) or a positive result by in situ hybridization (ISH), optionally combined with a IHC2+ score. * Diagnosis of locally advanced or metastatic HER2+ breast cancer, including patients with brain metastases. * Prior treatment with at least two prior anti-HER2-based regimens. * Decision for treatment with tucatinib in combination with trastuzumab and capecitabine according to current SmPC of tucatinib either in 1st/2nd palliative treatment line (Cohort 1) or 3rd/4th palliative treatment line (Cohort 2). * Progression after or intolerance of last systemic anti-HER2-based therapy. * Indication for treatment with tucatinib as assessed by the treating physician. * Signed written informed consent (only if patient is alive at time of inclusion, not applicable for retrospective inclusion of deceased patients). * Knowledge of German language. * Other criteria according to current SmPC of tucatinib Exclusion Criteria: * Contraindications according to SmPC of tucatinib * Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial. * Treatment with tucatinib/trastuzumab/capecitabine (=study treatment) in 5th or higher palliative therapy line. * Onset of tucatinib treatment later than 22 days after start of therapy line (in case tucatinib administration is started later than trastuzumab and/or capecitabine for any reason)

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Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma

As listed by the trial registrant

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

HER2-positive breast cancer

Contacts and locations

Locations

  • Medizinische Universität Wien, Innere Medizin I, Hämatologie und Onkologie

    Vienna, 1090, Austria

  • Universitätsklinikum Essen, Innere Klinik (Tumorforschung)

    Essen, North Rhine-Westphalia, D-45112, Germany

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