NCT06927648

CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objectives of this study are to assess the safety and effectiveness of Capivasertib (hereinafter "the study drug") in a real-world practice setting for patients prescribed with the study drug under the approved local label in South Korea. Primary Objective To assess the safety of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea Secondary Objective To assess effectiveness of the study drug in patients prescribed with the study drug under the approved label(s) in South Korea

Conditions

• Breast Cancer

Timeline

• Start date: 2025-10-15
• Primary completion: 2029-12-30
• Completion: 2029-12-30
• First posted: 2025-04-15
• Last updated: 2025-10-29

Locations

8 sites across 1 country: South Korea