A Post Marketing Surveillance on Piqray in Korea
A Post Marketing Surveillance on Piqray (Alpelisib) in Korea
ClinicalTrials.gov Identifier: NCT05293470
Novartis Reference Number: CBYL719CKR01
Last Update: Sep 06, 2022
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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
Eligibility Criteria
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.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]