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

Recruiting

• Conditions: Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
• Interventions: Other: Alpelisib; Other: Fulvestrant

• Registration Number: NCT04967248
• Lead Sponsor: Novartis Pharmaceuticals

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-19
• Study Start: 2023-06-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21
• Primary Completion: 2025-12-19
• Study Completion: 2025-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
alpelisib in combination with fulvestrant	Fulvestrant	Patients treated with alpelisib in combination with fulvestrant
alpelisib in combination with fulvestrant	Alpelisib	Patients treated with alpelisib in combination with fulvestrant

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Calculated BMI	Baseline	Calculated BMI will be collected
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
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 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
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Barcelona, Catalunya, Spain