Recruiting NCT06927648

CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Breast Cancer. Basic parameters: from 19 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: South Korea
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs) [Time frame: 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.]

Secondary outcome measures (1)

Real-world progression free survival (rwPFS) [Time frame: 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

South Korea · 17 centers

Research Site — Busan
Research Site — Busan
Research Site — Busan
Research Site — Daejeon
Research Site — Daejeon
Research Site — Goyang-si
Research Site — Goyang-si
Research Site — Guri-si
… and 9 more centers

Identifiers

NCT: NCT06927648 · D3612R00011

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗