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
Inclusion Criteria4
- 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 Criteria6
- 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.
Interventions
OTHERPiqray
There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT05293470
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