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

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. 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