A Post Marketing Surveillance on Piqray in Korea

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Post Marketing Surveillance on Piqray (Alpelisib) in Korea

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Piqray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects eligible for this study must meet all of the following criteria: Postmenopausal women and men who have a confirmed diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer. Patients who have progressed on prior endocrine based therapy and are going to start Piqray treatment for the first time in accordance with the locally approved label. Patients who are willing to provide written informed consent Exclusion Criteria: Subjects eligible for this study must not meet the following criteria: Patients with contraindication according to prescribing information for Piqray in Korea. - Severe hypersensitivity to Piqray or to any of its components Female subjects who are pregnant and nursing (lactating) Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray. Participants who receive or are going to receive any investigational medicine during surveillance period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Piqray<br>Patients prescribed with Piqray | Other: Piqray<br>* There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.<br>* Other names: Alpelisib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs | Incidence of AEs, including SAEs and ADRs | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rates (ORRs) | Objective response rates (ORRs). ORR is defined as the proportion of treated patients who achieve a best overall response (BOR) of partial response (PR) or complete response (CR) according to the response evaluation criteria in solid tumors (RECIST) version 1.1. | Up to 24 weeks | 
| Prescription dose of Piqray in combination with fulvestrant | Prescription dose of Piqray in combination with fulvestrant | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, NIS, Piqray, Korea, Alpelisib