Status:
NOT_YET_RECRUITING
A Study to Learn More About Tukysa Once it is Out in the Korean Market
Lead Sponsor:
Pfizer
Conditions:
HER2-positive Locally Advanced Unresectable
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy informatio...
Detailed Description
The purpose of this study is to understand the safety of Tukysa (Tucatinib hemiethanolate) once it is out in the Korean market. Tukysa will be given to participants aged 18 or over in Republic of Kore...
Eligibility Criteria
Inclusion
- Inclusion criterias.
- Patient who is treated with TUKYSA according to the current TUKYSA label for the approved indication.
- Patient who is treated with TUKYSA for the first time.
- Patient who is aged 18 or over.
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2027
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06873191
Start Date
January 1 2027
End Date
May 1 2029
Last Update
November 17 2025
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