Study identification

PURI

https://redirect.ema.europa.eu/resource/46588

EU PAS number

EUPAS42022

Study ID

46588

Official title and acronym

Survey among healthcare professionals treating patients with metastatic breast cancer in selected European countries to evaluate their knowledge on management of hyperglycemia when using alpelisib

DARWIN EU® study

No

Study countries

Austria
Croatia
Finland
Italy
Luxembourg
Netherlands
Norway
Poland
Slovenia
Spain
Sweden

Study description

In the EU/EEA Piqray (alpelisib) is indicated in combination with fulvestrant for postmenopausal women and men, with HR-positive HER2-negative, locally advanced or metastatic breast cancer (MBC) with PIK3CA mutation after disease progression, following endocrine monotherapy. Hyperglycemia is an expected effect of PI3K inhibition. To minimize the risk of hyperglycemia, Piqray was approved with a requirement for additional risk minimization measure using an educational material for oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA, containing guidance for the management of hyperglycemia. The Piqray European Risk Management Plan (RMP) requires Novartis to conduct a Post-authorisation Safety Study (PASS) to assess the effectiveness of the educational material. This study is designed and conducted in accordance with Good Pharmacovigilance Practices Modules VIII and XVI for Category 3 PASS. This is a multinational, non-interventional, cross-sectional survey among HCPs based in the EU/EEA who prescribe Piqray. It will assess HCPs’ knowledge of the management of hyperglycemia in patients treated with Piqray, with a minimum of 100 completed surveys. A sample of HCPs who may/do prescribe Piqray and care for patients with locally advanced or MBC will be included. Recruitment will start a minimum of 6 months following reimbursement and availability on the market of Piqray in each participating country. A web-based survey will be used in all countries. Data collected will include receipt and reading of the educational material, and knowledge of key messages included in the material. The survey is anticipated to be open for 3 months in each country. Follow-up reminders will be sent to non-respondents to support achieving the target sample size & reduce the impact of selection bias.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Novartis Clinical Disclosure Officer

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
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

byl719c2005--protocol_12-_Redacted

English (1.76 MB - PDF)View document
Updated protocol

byl719c2005-01--protocol amendment_Redacted.pdf

English (2.14 MB - 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)