Recruiting

CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

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.

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ClinicalTrials.gov IDNCT06927648

PhaseNot Applicable

Enrollment130

SponsorAstraZeneca

Age19 Years and older

SexALL

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Conditions studied

Breast Cancer

About this study

Primary outcomes

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.)

Eligibility information

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 locations

Research Site, Busan, 34084 South Korea
Research Site, Busan, 49241 South Korea
Research Site, Busan, 49267 South Korea
Research Site, Daejeon, 34943 South Korea
Research Site, Daejeon, 35015 South Korea
Research Site, Goyang-si, 10380 South Korea
Research Site, Goyang-si, 10408 South Korea
Research Site, Guri-si, 11923 South Korea
Research Site, Incheon, 21565 South Korea
Research Site, Incheon, 22332 South Korea

Showing 10 of 17 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-10.