Study identification

PURI

https://redirect.ema.europa.eu/resource/48553

EU PAS number

EUPAS41010

Study ID

48553

Official title and acronym

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

DARWIN EU® study

No

Study countries

Austria
Croatia
Czechia
Denmark
Finland
Greece
Hungary
Italy
Netherlands
Norway
Poland
Slovenia
Spain
Sweden

Study description

This Post-Authorization Safety study is a non-interventional study to further evaluate the safety of alpelisib in combination with fulvestrant in postmenopausal woman and men with HR+,HER2-, locally advanced or metastatic breast cancer with PIK3CA mutation, after disease progression following endocrine therapy as monotherapy, in the real-world setting.

Study status

Discontinued
Research institutions and networks

Institutions

Contact details

Novartis Clinical Disclosure Office

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG
Study protocol
Initial protocol

BYL719C2404-v00--protocol Mar2021_Redacted

English (482.45 KB - PDF)View document
Updated protocol

BYL719C2404-v02--protocol amendment_Redacted

English (576.04 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)