Clinical Trials in South Korea / NCT05293470
Recruiting
Observational
A Post Marketing Surveillance on Piqray in Korea
NCT05293470 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Breast Cancer
Investigational drug(s) / intervention(s)
Piqray
Piqray: There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.
Study 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
Inclusion Criteria:
Subjects eligible for this study must meet all of the following criteria:
1. 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.
2. 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.
3. Patients who are willing to provide written informed consent
Exclusion Criteria:
Subjects eligible for this study must not meet the following criteria:
1. Patients with contraindication according to prescribing information for Piqray in Korea.
\- Severe hypersensitivity to Piqray or to any of its components
2. Female subjects who are pregnant and nursing (lactating)
3. Patients who are sexually active but not willing to follow contraceptive precautions during taking Piqray.
4. Participants who receive or are going to receive any investigational medicine during surveillance period.
Primary outcome measure(s)
- Incidence of AEs — 24 weeks
Incidence of AEs, including SAEs and ADRs
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | Cheonan Si | Chungcheongnam-do | Recruiting |
| Novartis Investigative Site | Daegu | Dalseo gu | Recruiting |
| Novartis Investigative Site | Goyang-si | Gyeonggi-do | Recruiting |
| Novartis Investigative Site | Suwon | Gyeonggi-do | Recruiting |
| Novartis Investigative Site | Gyeonggi-do | Korea | Recruiting |
| Novartis Investigative Site | Seoul | Korea | Recruiting |
| Novartis Investigative Site | Seoul | Seoul | Completed |
| Novartis Investigative Site | Seoul | Seoul | Recruiting |
| Novartis Investigative Site | Seoul | Yangcheon gu | Recruiting |
| Novartis Investigative Site | Busan | South Korea | Recruiting |
| Novartis Investigative Site | Busan | South Korea | Recruiting |
| Novartis Investigative Site | Daegu | South Korea | Recruiting |
| Novartis Investigative Site | Daejeon | South Korea | Recruiting |
| Novartis Investigative Site | Jeollanam | South Korea | Recruiting |
| Novartis Investigative Site | Kyunggi | South Korea | Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Recruiting |
| Novartis Investigative Site | Seoul | South Korea | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05293470 on ClinicalTrials.gov ↗ ← All trials in South Korea