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Recruiting NCT06927648

CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

Trial Parameters

Condition Breast Cancer
Sponsor AstraZeneca
Study Type OBSERVATIONAL
Phase N/A
Enrollment 130
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2025-10-15
Completion 2029-12-30

Brief Summary

To fulfil the post-approval commitment of MFDS to conduct post-marketing surveillance, this study is designed to assess the known safety profile, identify previously unsuspected adverse reactions and to evaluate the effectiveness of Capivasertib under conditions of routine daily medical practice in Korea.

Eligibility Criteria

Inclusion Criteria: * Patients eligible for and treated with the study drug according to the approved label in South Korea * Patients who provide signed and dated written informed consent, either personally or through a legally acceptable representative. Exclusion Criteria: * Participation in any interventional trial during the treatment of the study drug * Other off-label indications according to the approved label in South Korea

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