Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

Inclusion Criteria:

- If female, patient is postmenopausal

- Patient has identified PIK3CA status

- Patients may be:

- relapsed with documented evidence of progression while on (neo) adjuvant
endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine
therapy with no treatment for metastatic disease;

- relapsed with documented evidence of progression more than 12 months from
completion of (neo)adjuvant endocrine therapy and then subsequently; progressed
with documented evidence of progression while on or after only one line of
endocrine therapy for metastatic disease;

- newly diagnosed advanced breast cancer, then relapsed with documented evidence of
progression while on or after only one line of endocrine therapy

- Patient has recurrence or progression of disease during or after AI therapy (i.e.

letrozole, anastrozole, exemestane).

- Patient has a histologically and/or cytologically confirmed diagnosis of
estrogen-receptor positive breast cancer by local laboratory and has HER2 negative
breast cancer

- Patient has either measurable disease per RECIST 1.1 criteria OR at least one
predominantly lytic bone lesion must be present

- Patient has adequate bone marrow function

Exclusion Criteria:

- Patient with symptomatic visceral disease or any disease burden that makes the patient
ineligible for endocrine therapy per the investigator's best judgment

- Patient has received prior treatment with chemotherapy (except for neoadjuvant/
adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment
with CDK4/6 inhibitors is allowed)

- Patient with inflammatory breast cancer at screening

- Patients with Child pugh score B or C

- Patients with an established diagnosis of diabetes mellitus type I or not controlled
type II

- Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more

- Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy
completion to starting the study treatment and has stable CNS tumor at time of
screening and not receiving steroids and/or enzyme inducing ant-epileptic medications
for brain metastases

- Patient has participated in a prior investigational study within 30 days prior to
enrollment or within 5 half-lives of the investigational product, whichever is longer

- Patient has a history of acute pancreatitis within 1 year of screening or a past
medical history of chronic pancreatitis

- Patient who relapsed with documented evidence of progression more than 12 months from
completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease

Other protocol-defined inclusion/esclusion criteria may apply.