Thinking of joining a study?

Register your interest

NCT06927648 | NOT YET RECRUITING | Breast Cancer


CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA
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.

Condition or disease

Breast Cancer

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 Type : OBSERVATIONAL
Estimated Enrollment : 130 participants
Official Title : CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA
Actual Study Start Date : 2025-12-31
Estimated Primary Completion Date : 2030-02-28
Estimated Study Completion Date : 2030-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

Location Details

NCT06927648


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


No Location Found

Loading...