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

NCT05073120 | Completed

• 1 other identifier: CBYL719C2005
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

educational material; PASS

Outcome Measures

Primary Outcomes (1)

• assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia

  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).

  Throughout study completion, an average of 1 year

Secondary Outcomes (3)

• Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemia

  Throughout study completion, an average of 1 year

• Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia

  Throughout study completion, an average of 1 year

• Assess the primary source from which HCPs learned about the messages included in the Piqray Prescriber's/HCP Guide for hyperglycemia

  Throughout study completion, an average of 1 year

Study Arms (1)

Piqray Prescriber's/HCP receiving the guide for hyperglycemia

HCPs prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).

Other: Piqray Prescriber's/HCP guide for hyperglycemia

Interventions

Piqray Prescriber's/HCP guide for hyperglycemia OTHER

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.

Piqray Prescriber's/HCP receiving the guide for hyperglycemia

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Basel, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 11, 2021
• Study Start: February 28, 2022
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)