- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04967248
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
September 19, 2023 updated by: Novartis Pharmaceuticals
Alpelisib (Piqray®) Post-Authorization Safety Study (PASS): a Non-interventional Study of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-), Locally Advanced or Metastatic Breast Cancer With a Phosphatidylinositol-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This is a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Once the patient provides informed consent, he or she is enrolled in the study.
Patients will be followed from enrollment until 1) 30 days after alpelisib treatment discontinuation, or 2) death, or 3) lost to follow-up, or 4) patient withdrawal, or 5) physician decision to end treatment/study, or 6) end of the study, whichever occurs first.
The end of the study is defined as a maximum of 12 months after the date the last patient was enrolled (LPFV); if the last patient is still on treatment on that date, they will not be followed up any further
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Novartis Pharmaceuticals
- Phone Number: +41613241111
- Email: novartis.email@novartis.com
Study Contact Backup
- Name: Novartis Pharmaceuticals
Study Locations
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Vienna, Austria, 1090
- Withdrawn
- Novartis Investigative Site
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Novara, Italy, 28100
- Recruiting
- Novartis Investigative Site
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CR
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Cremona, CR, Italy, 26100
- Recruiting
- Novartis Investigative Site
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Chieti
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Verduno, Chieti, Italy, 12060
- Recruiting
- Novartis Investigative Site
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FG
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Foggia, FG, Italy, 71122
- Recruiting
- Novartis Investigative Site
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PI
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Pontedera, PI, Italy, 56025
- Recruiting
- Novartis Investigative Site
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PR
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Parma, PR, Italy, 43100
- Recruiting
- Novartis Investigative Site
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PV
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Pavia, PV, Italy, 27100
- Recruiting
- Novartis Investigative Site
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Catalunya
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Barcelona, Catalunya, Spain, 08036
- Recruiting
- Novartis Investigative Site
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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
Postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.
Description
Inclusion Criteria:
- Signed informed consent from the patient or a legally acceptable representative, obtained before any study-related activities are undertaken
- Patients diagnosed with HR+, HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation
- Patients who have disease progression following endocrine therapy as monotherapy
- Patients must be postmenopausal women, or men, ≥18 years of age
- Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant
Exclusion Criteria:
- Use of alpelisib prior to signing the informed consent form for this study
- Participation in an interventional study within 30 days prior to the initiation of alpelisib
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
alpelisib in combination with fulvestrant
Patients treated with alpelisib in combination with fulvestrant
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Prospective observational PASS study.
There is no treatment allocation.
Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant will be enrolled.
Prospective observational PASS study.
There is no treatment allocation.
Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant will be enrolled.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence proportion of hyperglycemia
Time Frame: Up to 53 months
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To assess the incidence of hyperglycemia (Adverse Event of Special Iinterest) observed during follow-up of patients treated with alpelisib in combination with fulvestrant.
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Up to 53 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calculated BMI
Time Frame: Baseline
|
Calculated BMI will be collected
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Baseline
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Medical history
Time Frame: Baseline
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Number of patients with diabetes mellitus (including gestational diabetes), tobacco use, baseline diabetic status per laboratory values for HbA1c and FPG
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Baseline
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Family history of diabetes mellitus
Time Frame: Baseline
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Yes/ No variable
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Baseline
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Number of patients with concomitant medications known to affect blood glucose levels
Time Frame: Baseline
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Number of patients with concomitant medications known to affect blood glucose levels will be measured
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Baseline
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Number of participants with incidence proportion of ketoacidosis and Hyperglycemic Hyperosmolar Non-Ketotic Syndrome (HHNKS)
Time Frame: Up to 53 months
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Number of participants with incidence proportion of ketoacidosis and HHNKS based on AE data
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Up to 53 months
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Incidence of the Adverse Events of Special Interest (AESI) of Osteonecrosis of the Jaw (ONJ)
Time Frame: Up to 53 months
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Incidence of AESI of Osteonecrosis of the Jaw (ONJ) will be provided
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Up to 53 months
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Number of participants with risk factors for Osteonecrosis of the Jaw (ONJ) observed
Time Frame: Baseline
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Number of participants with risk factors for ONJ will be collected. Risk factors for ONJ include:
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Baseline
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Incidence proportion of AESIs
Time Frame: Up to 53 months
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The incidence proportion of AESIs:
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Up to 53 months
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Other safety and tolerability events
Time Frame: Up to 53 months
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The incidence proportion of:
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Up to 53 months
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Number of patients with hematological and biochemical laboratory abnormalities
Time Frame: Up to 53 months
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Number of patients with hematological and biochemical laboratory abnormalities will be provided
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Up to 53 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 21, 2023
Primary Completion (Estimated)
December 19, 2025
Study Completion (Estimated)
December 19, 2025
Study Registration Dates
First Submitted
July 8, 2021
First Submitted That Met QC Criteria
July 8, 2021
First Posted (Actual)
July 19, 2021
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 19, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Disease Attributes
- Breast Diseases
- Disease Progression
- Breast Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Fulvestrant
Other Study ID Numbers
- CBYL719C2404
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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