Study identification

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) required Novartis to conduct a Post-authorisation Safety Study (PASS) to assess the effectiveness of the educational material. This study was designed and conducted in accordance with Good Pharmacovigilance Practices Modules VIII and XVI for Category 3 PASS.
This was a multinational, non-interventional, cross-sectional survey among HCPs based in the EU/EEA who prescribe Piqray.
The primary objective of the survey was to assess the knowledge of HCPs who prescribe Piqray, specifically regarding their understanding and management of hyperglycemia in patients who are being treated with Piqray.
As per RMP requirement, the survey endeavored to collect a minimum of 100 completed surveys. HCPs were recruited from a targeted population of those who prescribe Piqray and were included in the distribution lists for the Piqray Prescriber’s/HCP Guide for hyperglycemia.
Recruitment took place after at least 6 months following reimbursement and launch of Piqray in each participating country.
A web-based survey was used in all countries.
Data collected included receipt and reading of the educational material, and knowledge of key messages included in the material.
Follow-up reminders were sent to non-respondents to support achieving the target sample size and reducing the impact of selection bias.

Study status

Finalised
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:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG
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)