A Post Marketing Surveillance on Piqray in Korea
Recruiting · NCT05293470 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
Piqray
What this trial is about
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
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
19 locations listed.
- Novartis Investigative Site - Busan, South Korea
- Novartis Investigative Site - Busan, South Korea
- Novartis Investigative Site - Daegu, South Korea
- Novartis Investigative Site - Daejeon, South Korea
- Novartis Investigative Site - Jeollanam, South Korea
- Novartis Investigative Site - Kyunggi, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Cheonan Si, Chungcheongnam-do, South Korea
- Novartis Investigative Site - Daegu, Dalseo gu, South Korea
- Novartis Investigative Site - Goyang-si, Gyeonggi-do, South Korea
- Novartis Investigative Site - Suwon, Gyeonggi-do, South Korea
- Novartis Investigative Site - Gyeonggi-do, Korea, South Korea
- Novartis Investigative Site - Seoul, Korea, South Korea
- Novartis Investigative Site - Seoul, Seoul, South Korea
- Novartis Investigative Site - Seoul, Seoul, South Korea
- Novartis Investigative Site - Seoul, Yangcheon gu, South Korea