Clinical Trials

Inclusion Criteria:

• Male or postmenopausal female
• Has identified PIK3CA status
• May be
  • Relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
  • Relapsed with documented evidence of progression on 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 adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression after one line of endocrine therapy for metastatic disease
  • Newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression after one line of endocrine therapy
  • Has recurrence or progression of disease during or after AI therapy (i.e letrozole, anastrozole, exemestane)
• Has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer
• Has either measurable disease per RECIST 1.1 criteria or at least one predominantly lytic bone lesion must be present
• Has adequate bone marrow function

Exclusion Criteria

• Symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment
• 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
• Inflammatory breast cancer at screening
• Child pugh score B or C
• An established diagnosis of diabetes mellitus type I or not controlled type II
• Eastern Cooperative Oncology Group (ECOG) performance status 2 or more
• CNS involvement unless 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 anti-epileptic medications for brain metastases
• 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
• Has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
• Other protocol-defined inclusion/esclusion criteria may apply