A Post Marketing Surveillance on Piqray in Korea

Recruiting now

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT05293470

Run by

Novartis Pharmaceuticals

People needed

900

Starts

2022-06-29

Expected to finish

2027-05-12

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Novartis Investigative Site — Seoul, South Korea (enrolling)
• Novartis Investigative Site — Daegu, Dalseo gu, South Korea (enrolling)
• Novartis Investigative Site — Goyang-si, Gyeonggi-do, South Korea (enrolling)
• Novartis Investigative Site — Suwon, Gyeonggi-do, South Korea (enrolling)
• Novartis Investigative Site — Gyeonggi-do, Korea, South Korea (enrolling)
• Novartis Investigative Site — Seoul, Korea, South Korea (enrolling)
• Novartis Investigative Site — Cheonan Si, Chungcheongnam-do, South Korea (enrolling)
• Novartis Investigative Site — Seoul, Seoul, South Korea (enrolling)
• Novartis Investigative Site — Seoul, Yangcheon gu, South Korea (enrolling)
• Novartis Investigative Site — Busan, South Korea (enrolling)
• Novartis Investigative Site — Busan, South Korea (enrolling)
• Novartis Investigative Site — Daegu, South Korea (enrolling)
• Novartis Investigative Site — Daejeon, South Korea (enrolling)
• Novartis Investigative Site — Jeollanam, South Korea (enrolling)
• Novartis Investigative Site — Kyunggi, South Korea (enrolling)
• Novartis Investigative Site — Seoul, South Korea (enrolling)
• Novartis Investigative Site — Seoul, South Korea (enrolling)
• Novartis Investigative Site — Seoul, South Korea (enrolling)
• Novartis Investigative Site — Seoul, Seoul, South Korea

Full record on ClinicalTrials.gov

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