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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04967248

Collaborator

(none)

150

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation	Other: Alpelisib Other: Fulvestrant

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 3, 2022

Anticipated Primary Completion Date :

May 5, 2026

Anticipated Study Completion Date :

May 5, 2026

Arms and Interventions

Arm	Intervention/Treatment
alpelisib in combination with fulvestrant Patients treated with alpelisib in combination with fulvestrant	Other: Alpelisib 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. Other: Fulvestrant 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.

Arm

Intervention/Treatment

alpelisib in combination with fulvestrant

Patients treated with alpelisib in combination with fulvestrant

Other: Alpelisib

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.

Other: Fulvestrant

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.

Outcome Measures

Primary Outcome Measures

Incidence proportion of hyperglycemia [Up to 53 months]
To assess the incidence of hyperglycemia (Adverse Event of Special Iinterest) observed during follow-up of patients treated with alpelisib in combination with fulvestrant.

Secondary Outcome Measures

Calculated BMI [Baseline]
Calculated BMI will be collected
Medical history [Baseline]
Number of patients with diabetes mellitus (including gestational diabetes), tobacco use, baseline diabetic status per laboratory values for HbA1c and FPG
Family history of diabetes mellitus [Baseline]
Yes/ No variable
Number of patients with concomitant medications known to affect blood glucose levels [Baseline]
Number of patients with concomitant medications known to affect blood glucose levels will be measured
Number of participants with incidence proportion of ketoacidosis and Hyperglycemic Hyperosmolar Non-Ketotic Syndrome (HHNKS) [Up to 53 months]
Number of participants with incidence proportion of ketoacidosis and HHNKS based on AE data
Incidence of the Adverse Events of Special Interest (AESI) of Osteonecrosis of the Jaw (ONJ) [Up to 53 months]
Incidence of AESI of Osteonecrosis of the Jaw (ONJ) will be provided
Number of participants with risk factors for Osteonecrosis of the Jaw (ONJ) observed [Baseline]
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).
Incidence proportion of AESIs [Up to 53 months]
The incidence proportion of AESIs: GI toxicity (nausea, vomiting and diarrhea) Rash Hypersensitivity (e.g. anaphylactic reaction) Pancreatitis Pneumonitis SCARs
Other safety and tolerability events [Up to 53 months]
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
Number of patients with hematological and biochemical laboratory abnormalities [Up to 53 months]
Number of patients with hematological and biochemical laboratory abnormalities will be provided

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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