Clinical trial · Observational
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
NCT05073120CI-TRIAL-00090461completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Piqray Prescriber's/HCP guide for hyperglycemia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Piqray Prescriber's/HCP receiving the guide for hyperglycemia
- description
- HCPs prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).
- interventionNames
- Other: Piqray Prescriber's/HCP guide for hyperglycemia
Primary outcomes (1)
- measure
- assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia
- timeFrame
- Throughout study completion, an average of 1 year
- description
- The 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.