NCT05293470

A Post Marketing Surveillance on Piqray in Korea

A Post Marketing Surveillance on Piqray (Alpelisib) in Korea

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, open-label, non-comparative, non-interventional, observational study to assess te safety and effectiveness of Piqray in the real-world setting

Detailed description

The observation duration will be up to 24 weeks after enrollment, which is sufficient to provide adequate information about the safety and effectiveness of Piqray. If the subject does not return for a follow-up visit or stops taking Piqray for any reason, all data collected until the date of the last contact of the subject will be used. Patients will be followed up (safety follow up) for 30 days afetr either 24 weeks-treatment or early withdrawal.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Piqray	There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.

Timeline

• Start date: 2022-06-29
• Primary completion: 2027-05-12
• Completion: 2027-05-12
• First posted: 2022-03-24
• Last updated: 2025-07-09

Locations

17 sites across 1 country: South Korea