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

Not Yet RecruitingN/A

Sponsor: Pfizer

Conditions: HER2-positive Locally Advanced Unresectable, Metastatic Breast Cancer

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 information about the product in general practice in Korea. This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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.