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
Novartis Investigative Site
Recruiting
Parma,PR,43100,Italy
Novartis Investigative Site
Recruiting
Pavia,PV,27100,Italy
Novartis Investigative Site
Recruiting
Novara,28100,Italy
Novartis Investigative Site
Recruiting
Verduno,Chieti,12060,Italy
Novartis Investigative Site
Recruiting
Cremona,CR,26100,Italy
Novartis Investigative Site
Recruiting
Foggia,FG,71122,Italy
Novartis Investigative Site
Recruiting
Pontedera,PI,56025,Italy
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08036,Spain
Worldwide Contacts
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