Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

Inclusion Criteria:

- Locally advanced or metastatic breast cancer

- HER2-negative and hormone receptor-positive status (common breast cancer
classification tests)

- Postmenopausal woman

- A tumor sample must be shipped to a Novartis designated laboratory for identification
of biomarkers (PI3K activation status)

- Progression or recurrence of breast cancer while on or after aromatase inhibitor
treatment

- Measurable disease or non measurable disease bone lesions in the absence of measurable
disease as per RECIST 1.1

- Adequate bone marrow and organ function defined by laboratory values

Exclusion Criteria:

- Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant

- More than one prior chemotherapy line for metastatic disease

- Symptomatic brain metastases

- Increasing or chronic treatment (> 5 days) with corticosteroids or another
immunosuppressive agent

- Active heart (cardiac) disease as defined in the protocol

- Certain scores on an anxiety and depression mood questionnaires

- Other protocol-defined inclusion/exclusion criteria may apply