A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

Inclusion Criteria:

- Breast cancer that is locally advanced or metastatic

- HER2 negative disease, and a known hormone receptor status (common breast cancer
classification tests)

- A tumor sample must be shipped to a central lab for identification of biomarkers
(PI3K activation status) before randomization

- Adequate bone marrow and organ function

- Measurable or non-measurable disease

Exclusion Criteria:

- Prior chemotherapy for locally advanced or metastatic disease

- Previous treatment with PI3K or AKT inhibitors

- Symptomatic brain metastases

- Concurrent malignancy or malignancy within 3 years prior to start of study treatment

- Certain drugs or radiation within 2-4 weeks of enrollment

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

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

- Known hypersensitivity or contraindications to use paclitaxel

- Pregnant or nursing (lactating) woman

- Certain scores on an anxiety and depression mood questionaire given at screening

- Other protocol defined criteria may apply