CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

AstraZeneca

Status: Enrolling

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT06927648

D3612R00011

Details and patient eligibility

About

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.

Full 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

Enrollment: 130 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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