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Clinical Trials in South Korea / NCT06927648
Recruiting Observational

CAPIVASERTIB REGULATORY POSTMARKETING SURVEILLANCE IN KOREA

NCT06927648 · tracked via the Priya Life Science South Korea tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2025-10-15
Last updated
2026-09-09

Condition(s) studied

Breast Cancer

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Adverse Events (AEs)·Adverse Drug Reactions (ADRs) Serious Adverse Events (SAEs)·Adverse Drug Reactions (SADRs) Unexpected Adverse Events (AEs)·Adverse Drug Reactions (ADRs) — 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.
    The safety assessment should include all undesirable changes in medical findings (including clinical test findings) noted during medical visits as required by local practice guidelines, as well as all AEs associated with the study drug administration.

Trial sites (17)

FacilityCityRegionStatus
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

More AstraZeneca trials in South Korea

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A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations Active, not recruiting
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT Recruiting

Other trials for the same condition

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Recruiting
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting
Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer Recruiting
Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer Recruiting
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06927648 on ClinicalTrials.gov ↗ ← All trials in South Korea