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

Prior treatment

• 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 had surgery within 14 days prior to starting study drug or has not recovered from major side effects

Other illness

• 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 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 currently documented pneumonitis /interstitial lung disease
• History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
• Participant has a history of severe cutaneous reactions
  • Other protocol-defined inclusion/exclusion criteria may apply

Lab values

• Participant with an established diagnosis at screening of diabetes mellitus type I or not controlled type II (based on FPG and HbA1c)

Other

• Participant with unresolved osteonecrosis of the jaw

• Japanese man or postmenopausal woman
• Participant has adequate tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory.
• Participant has identified PIK3CA mutation (as determined by a Novartis designated laboratory)
• Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory
• Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH or SISH) test is required by local laboratory testing
• Participant has measurable disease, i.e., at least one measurable lesion as per RECIST 1.1
• Participant has advanced breast cancer
• Participant has ECOG performance status 0 or 1