CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06927648
• Lead Sponsor: AstraZeneca

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.

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

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Study Start: 2025-12-31
• Primary Completion: 2030-02-28
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs)	For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die. 30 days addtional follow up in case of not completing 12 months.	The safety assessment should include all undesirable changes in medical findings (including clinical test findings) noted during medical visits as required by local practice guidelines, as well as all AEs associated with the study drug administration.

Secondary Outcome Measures

Name	Time	Method
Real-world progression free survival (rwPFS)	For about 12 months from the first dose of the study drug unless they withdraw consent, are lost to follow-up, experience disease progression, or die	Real-world progression free survival (rwPFS) for patients will be evaluated by routine clinical practice of the investigators. rwPFS will be defined as the time from first dose of the study drug until the date of disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from therapy or receives another anti-cancer therapy prior to progression.Subjects who have not progressed or died at the time of analysis will be censored at the date of their last follow-up assessment.