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
Procedures
No information provided.