Breast CancerNCT05073120
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
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Piqray Prescriber's/HCP guide for hyperglycemia
- How many people
- 103 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Feb 2022to 5 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).
Who may be able to join
- 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.
Who cannot join
- HCPs who are direct employees of Novartis, the EMA (or any other regulatory bodies), or ICON.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Piqray Prescriber's/HCP guide for hyperglycemia
- Keywords
- educational material, PASS
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piqray Prescriber's/HCP guide for hyperglycemiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Piqray Prescriber's/HCP guide for hyperglycemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Assessed as the percentages of HCPs who report receipt and reading of the same (survey questions 1, 2).
Measured: Throughout study completion, an average of 1 year
Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia
Assessed as the percentages of HCPs with correct responses to each question (individual responses to survey questions 4-15).
Measured: 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
Assessed as the percentages of HCPs who report using each of the possible sources as the primary source they used (survey question 3).
Measured: Throughout study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start28 Feb 2022
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073120
- Sponsor's protocol ID
- CBYL719C2005
- Status last verified
- May 2025
- First submitted
- 15 Sep 2021
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05073120
- Acronym / sponsor ID
- CBYL719C2005
- Conditions
- Breast Cancer
- Keywords
- educational material, PASS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Piqray Prescriber's/HCP receiving the guide for hyperglycemia | – | Other: Piqray Prescriber's/HCP guide for hyperglycemiaHCPs prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- HCPs who are direct employees of Novartis, the EMA (or any other regulatory bodies), or ICON.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piqray Prescriber's/HCP guide for hyperglycemiaoncologists/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. | Other | Piqray Prescriber's/HCP receiving the guide for hyperglycemia |
Primary outcome
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).
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.