A Post Marketing Surveillance on Piqray in Korea
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
- Condition
- Breast Cancer
- Tested
- Piqray
- Sponsor
- Novartis Pharmaceuticals
Who can join
- Age
- 18 to 100 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Maximum age: 100 years
- Study condition: Breast Cancer
- 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 6
- 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
19 sites, 18 recruiting
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Cheonan Si, Chungcheongnam-do, South Korea
Novartis Investigative Site
Daegu, Dalseo gu, South Korea
Novartis Investigative Site
Daegu, South Korea
Novartis Investigative Site
Daejeon, South Korea
and 13 more sites on ClinicalTrials.gov
Contact
-
Novartis Pharmaceuticals
+41613241111 novartis.email@novartis.com
-
Novartis Pharmaceuticals
Potential match only. Final eligibility is determined by the study team.