Monitoring capivasertib safety and effectiveness in Korean patients
CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA
This project will see how safe and effective capivasertib is for people in Korea who are prescribed it for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 17 sites (Busan and 16 other locations) |
| Trial ID | NCT06927648 on ClinicalTrials.gov |
What this trial studies
This is an observational post-marketing surveillance program to collect real-world safety and effectiveness data on capivasertib when used under its approved label in South Korea. Patients prescribed capivasertib at participating clinical sites will be followed during routine care to capture adverse reactions, unexpected events, and measures of treatment effect. No experimental interventions are assigned; data are collected from clinical records and patient follow-up after informed consent. The goal is to complement clinical trial data with practical information about how the drug performs in everyday medical practice in Korea.
Who should consider this trial
Good fit: Adults in Korea with breast cancer who are prescribed capivasertib according to the approved local label and can provide informed consent are the intended participants.
Not a fit: People using capivasertib off-label, enrolled in interventional trials, or unable to give informed consent are excluded and unlikely to benefit from this surveillance.
Why it matters
Potential benefit: If successful, the program could improve understanding of capivasertib's real-world safety and help clinicians use it more safely and effectively for patients in Korea.
How similar studies have performed: Although clinical trials have characterized capivasertib's safety and activity, there is limited post-marketing real-world data in Korea, so this surveillance provides information not fully captured in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Busan and 16 other locations
- Research Site — Busan, South Korea (Not_yet_recruiting)
- Research Site — Busan, South Korea (Not_yet_recruiting)
- Research Site — Busan, South Korea (Recruiting)
- Research Site — Daejeon, South Korea (Not_yet_recruiting)
- Research Site — Daejeon, South Korea (Recruiting)
- Research Site — Goyang-si, South Korea (Recruiting)
- Research Site — Goyang-si, South Korea (Recruiting)
- Research Site — Guri-si, South Korea (Recruiting)
- Research Site — Incheon, South Korea (Recruiting)
- Research Site — Incheon, South Korea (Recruiting)
- Research Site — Seongnam-si, South Korea (Not_yet_recruiting)
- Research Site — Seoul, South Korea (Recruiting)
- Research Site — Seoul, South Korea (Recruiting)
- Research Site — Seoul, South Korea (Not_yet_recruiting)
- Research Site — Seoul, South Korea (Recruiting)
- Research Site — Suwon, South Korea (Recruiting)
- Research Site — Uijeongbu-si, South Korea (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.