Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

Exclusion Criteria

• •Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the investigator's best judgment
• •Participant has received prior treatment;
• •with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor for Cohort 1 and 3
• •with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR, AKT inhibitor or CDK 4/6 inhibitor for Cohort 2
• •Participant has a known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant
• •Participant with inflammatory breast cancer at screening
• •Participant is concurrently using other anti-cancer therapy
• •Participant has had surgery within 14 days prior to starting study drug or has not recovered from major side effects
• •Participant with an established diagnosis at screening of diabetes mellitus type I or not controlled type II (based on FPG and HbA1c)
• •Participant has currently documented pneumonitis /interstitial lung disease
• •History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
• •Participant with unresolved osteonecrosis of the jaw
• •Participant has a history of severe cutaneous reactions