A Study to Learn More About Tukysa Once it is Out in the Korean Market

Launched by PFIZER · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called Tukysa, specifically for patients with a type of breast cancer known as HER2-positive locally advanced unresectable or metastatic breast cancer. The purpose of the study is to gather more information about how Tukysa works in everyday medical practice in Korea, focusing on how safe and effective it is for patients receiving this treatment.

To be eligible for the trial, patients need to be 18 years or older and must be using Tukysa for the first time, following the treatment guidelines approved for this medication. Participants will need to sign a consent form to show they understand the study and agree to take part. It's important to note that patients who cannot use Tukysa due to specific health reasons outlined in the medication's guidelines will not be able to participate. While recruitment for the trial has not started yet, it aims to ensure that Tukysa is used safely and effectively in the Korean healthcare system.

Gender

ALL

Eligibility criteria

• • 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.