Status:
RECRUITING
CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
All Genders
19+ years
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 ...
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 unde...
Eligibility Criteria
Inclusion
- 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
- Participation in any interventional trial during the treatment of the study drug
- Other off-label indications according to the approved label in South Korea
Key Trial Info
Start Date :
October 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2029
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06927648
Start Date
October 15 2025
End Date
December 30 2029
Last Update
October 29 2025
Active Locations (8)
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1
Research Site
Busan, South Korea, 49267
2
Research Site
Daejeon, South Korea, 34943
3
Research Site
Daejeon, South Korea, 35015
4
Research Site
Goyang-si, South Korea, 10380