Status:
RECRUITING
A Post Marketing Surveillance on Piqray in Korea
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
All Genders
18-100 years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 12 2027
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT05293470
Start Date
June 29 2022
End Date
May 12 2027
Last Update
July 9 2025
Active Locations (17)
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1
Novartis Investigative Site
Cheonan Si, Chungcheongnam-do, South Korea, 31116
2
Novartis Investigative Site
Daegu, Dalseo gu, South Korea, 42602
3
Novartis Investigative Site
Deogyang Gu Goyang Si, Gyeonggi-do, South Korea, 10475
4
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea, 16499