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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

Intervention / Treatment
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* Other: Alpelisib
* Other: Fulvestrant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| alpelisib in combination with fulvestrant<br>Patients treated with alpelisib in combination with fulvestrant | Other: Alpelisib<br>* 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.<br>Other: Fulvestrant<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence proportion of hyperglycemia | To assess the incidence of hyperglycemia (Adverse Event of Special Iinterest) observed during follow-up of patients treated with alpelisib in combination with fulvestrant. | Up to 53 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated BMI | Calculated BMI will be collected | Baseline | 
| Medical history | Number of patients with diabetes mellitus (including gestational diabetes), tobacco use, baseline diabetic status per laboratory values for HbA1c and FPG | Baseline | 
| Family history of diabetes mellitus | Yes/ No variable | Baseline | 
| Number of patients with concomitant medications known to affect blood glucose levels | Number of patients with concomitant medications known to affect blood glucose levels will be measured | Baseline | 
| Number of participants with incidence proportion of ketoacidosis and Hyperglycemic Hyperosmolar Non-Ketotic Syndrome (HHNKS) | Number of participants with incidence proportion of ketoacidosis and HHNKS based on AE data | Up to 53 months | 
| Incidence of the Adverse Events of Special Interest (AESI) of Osteonecrosis of the Jaw (ONJ) | Incidence of AESI of Osteonecrosis of the Jaw (ONJ) will be provided | Up to 53 months | 
| Number of participants with risk factors for Osteonecrosis of the Jaw (ONJ) observed | Number of participants with risk factors for ONJ will be collected. Risk factors for ONJ include: Patient characteristics: age, calculated BMI, sex Prior and/or concomitant use of bisphosphonates (e.g. zoledronic acid). Prior and/or concomitant use of RANKligand inhibitors (e.g. denosumab). | Baseline | 
| Incidence proportion of AESIs | The incidence proportion of AESIs: GI toxicity (nausea, vomiting and diarrhea) Rash Hypersensitivity (e.g. anaphylactic reaction) Pancreatitis Pneumonitis SCARs | Up to 53 months | 
| Other safety and tolerability events | The incidence proportion of: AEs AEs leading to dose interruptions AEs leading to dose reductions AEs leading to permanent discontinuation of alpelisib in combination with fulvestrant SAEs | Up to 53 months | 
| Number of patients with hematological and biochemical laboratory abnormalities | Number of patients with hematological and biochemical laboratory abnormalities will be provided | Up to 53 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, non-interventional study, NIS, alpelisib, fulvestrant, PASS