RecruitingNCT06927648

CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA


Sponsor

AstraZeneca

Enrollment

130 participants

Start Date

Oct 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This is a Korean post-marketing surveillance study that is monitoring the real-world safety and use of capivasertib — an AKT inhibitor drug used for certain breast cancers — in patients who are receiving it as part of their approved treatment in South Korea. **You may be eligible if...** - You are being prescribed capivasertib in South Korea for an approved indication (as per its label) - You have provided signed informed consent (or a legal representative has done so on your behalf) **You may NOT be eligible if...** - You are using capivasertib for a reason not listed on its approved South Korean label (off-label use) - You are already participating in another interventional clinical trial while on capivasertib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(17)

Research Site

Busan, South Korea

Research Site

Busan, South Korea

Research Site

Busan, South Korea

Research Site

Daejeon, South Korea

Research Site

Daejeon, South Korea

Research Site

Goyang-si, South Korea

Research Site

Goyang-si, South Korea

Research Site

Guri-si, South Korea

Research Site

Incheon, South Korea

Research Site

Incheon, South Korea

Research Site

Seongnam-si, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Suwon, South Korea

Research Site

Uijeongbu-si, South Korea

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NCT06927648


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