Actively Recruiting
Post-Marketing Observational Study of Piqray for Advanced Breast Cancer in Korea Monitoring Safety and Effectiveness up to 24 Weeks
Led by Novartis Pharmaceuticals · Updated on 2026-06-17
900
Participants Needed
19
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are observing the safety and effectiveness of Piqray Alpelisib in patients with advanced breast cancer in Korea. This observational study focuses on patients with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer who have progressed after prior endocrine therapy. The study aims to collect real-world data on Piqray use for up to 24 weeks. Participants prescribed Piqray will be followed during their treatment period, which lasts up to 24 weeks. If a participant stops taking Piqray or misses follow-up visits, all collected data until the last contact will be used. After treatment or early withdrawal, patients will have a safety follow-up for 30 days to monitor any adverse effects. During the study, researchers will collect information about side effects and treatment responses. They will review incidence of adverse events within 24 weeks and measure objective response rates and prescribed doses of Piqray combined with fulvestrant. Participants will be observed through visits and data collection over the treatment and follow-up periods to ensure comprehensive safety and effectiveness monitoring.
CONDITIONS
Brief Title
A Post Marketing Surveillance on Piqray in Korea
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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