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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05073120
Enrollment
103
Registered
2021-10-11
Start date
2022-02-28
Completion date
2024-06-05
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

educational material, PASS

Brief summary

This was a multinational, non-interventional, cross-sectional survey conducted among HCPs based in the EU/EEA who prescribe Piqray. The survey assessed the knowledge of HCPs prescribing Piqray in relation to the management of hyperglycemia in patients treated with Piqray.

Interventions

OTHERPiqray Prescriber's/HCP guide for hyperglycemia

oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA were provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material). The educational material aimed to provide oncologists/HCPs prescribing Piqray with additional measures/guidance prior to, and during treatment with Piqray for the identification and management of hyperglycemia.

Sponsors

Novartis Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Had prescribed Piqray to at least 1 locally advanced or MBC patient within 6 months prior to completing the survey. * Provided permission to share their anonymized responses in aggregate with EMA or NCAs, if requested.

Exclusion criteria

HCPs who are direct employees of Novartis, the EMA (or any other regulatory bodies), or ICON.

Design outcomes

Primary

MeasureTime frameDescription
assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemiaThroughout study completion, an average of 1 yearThe primary endpoint was a composite endpoint based on the percentages of HCPs with correct responses to all questions included in the composite regarding the below information: * Risk of hyperglycemia and its potential risk factors * Signs and symptoms of hyperglycemia * Recommendations for monitoring for hyperglycemia prior to, and during, treatment with Piqray * Recommendations for managing hyperglycemia during treatment with Piqray. Specifically, the primary endpoint was a weighted composite knowledge score aggregated across the following survey questions: 4A, 5A-C, 6, 8A-C, 10, and 12-15. It was calculated as the number of all correctly answered questions divided by the number of all answered questions (i.e. questions that were answered either correct and not correct - unanswered questions are excluded).

Secondary

MeasureTime frameDescription
Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemiaThroughout study completion, an average of 1 yearAssessed as the percentages of HCPs who report receipt and reading of the same (survey questions 1, 2).
Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemiaThroughout study completion, an average of 1 yearAssessed as the percentages of HCPs with correct responses to each question (individual responses to survey questions 4-15).
Assess the primary source from which HCPs learned about the messages included in the Piqray Prescriber's/HCP Guide for hyperglycemiaThroughout study completion, an average of 1 yearAssessed as the percentages of HCPs who report using each of the possible sources as the primary source they used (survey question 3).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026