A Post Marketing Surveillance on Piqray (Alpelisib) in Korea
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
⁃ 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
Locations
Other Locations
Republic of Korea
Novartis Investigative Site
RECRUITING
Busan
Novartis Investigative Site
RECRUITING
Busan
Novartis Investigative Site
RECRUITING
Cheonan Si
Novartis Investigative Site
RECRUITING
Daegu
Novartis Investigative Site
RECRUITING
Daegu
Novartis Investigative Site
RECRUITING
Daejeon
Novartis Investigative Site
RECRUITING
Deogyang Gu Goyang Si
Novartis Investigative Site
RECRUITING
Gyeonggi-do
Novartis Investigative Site
RECRUITING
Jeollanam
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
COMPLETED
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Seoul
Novartis Investigative Site
RECRUITING
Suwon
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2022-06-29
Estimated Completion Date: 2027-05-12
Participants
Target number of participants: 900
Treatments
Piqray
Patients prescribed with Piqray
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals