Study Description
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
Interventions
Alpelisib
Fulvestrant
Eligibility Criteria
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
Worldwide Contacts
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