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OpenTrials
Completed

NCT Number: NCT05073120

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 11, 2021
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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