Clinical trial · Observational
A Study to Learn More About Tukysa Once it is Out in the Korean Market
Post-Approval Safety Monitoring Program to Assess the Safety and Efficacy Profile of TUKYSA in Usual Practice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Locally Advanced Unresectable | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From Day 1 through Day 7 after administration. Administration and for 28 days following. The total follow-up period will not exceed 1 year.
- description
- The BOR from the start of treatment until progressive disease (PD)/recurrence will be recorded in the electronic Case Report Form as CR, PR, stable disease (SD), PD or Not Evaluable (NE). The BOR will be defined the best overall response recorded from the start of treatment until PD/recurrence.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available