RecruitingNCT05293470

A Post Marketing Surveillance on Piqray in Korea

A Post Marketing Surveillance on Piqray (Alpelisib) in Korea


Sponsor

Novartis Pharmaceuticals

Enrollment

900 participants

Start Date

Jun 29, 2022

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This is a post-marketing surveillance study monitoring how a drug called Piqray (alpelisib) performs in real-world use in South Korea. It tracks safety and outcomes in breast cancer patients who are already being prescribed this drug as part of their standard care. **You may be eligible if...** - You are a postmenopausal woman or a man - You have hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer (confirmed by testing) - Your cancer has progressed after hormone-based therapy - You are about to start Piqray for the first time - You are willing to provide written informed consent **You may NOT be eligible if...** - You have a contraindication to Piqray (e.g., severe allergy to it) - You have been previously treated with Piqray - You have type 1 or uncontrolled type 2 diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPiqray

There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.


Locations(17)

Novartis Investigative Site

Cheonan Si, Chungcheongnam-do, South Korea

Novartis Investigative Site

Daegu, Dalseo gu, South Korea

Novartis Investigative Site

Deogyang Gu Goyang Si, Gyeonggi-do, South Korea

Novartis Investigative Site

Suwon, Gyeonggi-do, South Korea

Novartis Investigative Site

Gyeonggi-do, Korea, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Daegu, South Korea

Novartis Investigative Site

Daejeon, South Korea

Novartis Investigative Site

Jeollanam, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05293470


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