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

May 28, 2025 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia
Time Frame: Throughout study completion, an average of 1 year

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemia
Time Frame: Throughout study completion, an average of 1 year
Assessed as the percentages of HCPs who report receipt and reading of the same (survey questions 1, 2).
Throughout study completion, an average of 1 year
Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia
Time Frame: Throughout study completion, an average of 1 year
Assessed as the percentages of HCPs with correct responses to each question (individual responses to survey questions 4-15).
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
Time Frame: Throughout study completion, an average of 1 year
Assessed as the percentages of HCPs who report using each of the possible sources as the primary source they used (survey question 3).
Throughout study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Actual)

June 5, 2024

Study Completion (Actual)

June 5, 2024

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 3, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBYL719C2005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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