Recruiting
A Post Marketing Surveillance on Piqray in Korea
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
ClinicalTrials.gov IDNCT05293470
PhaseNot Applicable
Enrollment900
SponsorNovartis Pharmaceuticals
Age18 Years
SexALL
Conditions studied
Breast Cancer
About this study
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
Interventions
- Other: Piqray — There is no treatment allocation. Patients administered Piqray by prescription will be enrolled.
Primary outcomes
- Incidence of AEs (24 weeks)
Eligibility information
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.
Study locations
- Novartis Investigative Site, Cheonan Si, Chungcheongnam-do 31116 South Korea
- Novartis Investigative Site, Daegu, Dalseo gu 42602 South Korea
- Novartis Investigative Site, Goyang-si, Gyeonggi-do 10475 South Korea
- Novartis Investigative Site, Suwon, Gyeonggi-do 16499 South Korea
- Novartis Investigative Site, Gyeonggi-do, Korea 11765 South Korea
- Novartis Investigative Site, Seoul, Korea 02841 South Korea
- Novartis Investigative Site, Seoul, Seoul 06351 South Korea
- Novartis Investigative Site, Seoul, Seoul 150-713 South Korea
- Novartis Investigative Site, Seoul, Yangcheon gu 07985 South Korea
- Novartis Investigative Site, Busan, 48108 South Korea
Showing 10 of 19 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.