Alpelisib (Piqray®) Post-Authorization Safety Study (PASS): a non-interventional study of alpelisib in combination with fulvestrant in postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), locally advanced or metastatic breast cancer with a phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) mutation, in the real-world setting

11/06/2021
13/10/2025
EU PAS number:
EUPAS41010
Study
Discontinued

ENCePP Code of conduct

No
Data sources

Data sources (types)

Other

Data sources (types), other

Prospective patient-based data collection
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

No