A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

Inclusion Criteria:

- Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not
amenable to curative treatment by surgery or radiotherapy.

- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast
cancer

- Postmenopausal women.

- Disease refractory to non steroidal aromatase inhibitors (NSAI),

- Radiological or objective evidence of recurrence or progression on or after the last
systemic therapy prior to randomization.

- Patients must have at least one lesion that can be accurately measured or bone
lesions in the absence of measurable disease

- Adequate bone marrow and coagulation function

- Adequate liver and renal function

- ECOG Performance Status = 2 or less

Exclusion Criteria:

- HER2-overexpressing patients

- Patients with only non-measurable lesions other than bone metastasis (e.g. pleural
effusion, ascites etc.).

- Patients who received more than one chemotherapy line for Advanced Breast Cancer.

- Previous treatment with exemestane or mTOR inhibitors.

- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin).

- Radiotherapy within four weeks prior to randomization

- Currently receiving hormone replacement therapy,

- Patients receiving immunosuppressive agents or chronic corticosteroids use

- Patients being treated with strong inhibitors or inducers of CYP3A within 5 days
prior to randomization

Other protocol-defined inclusion/exclusion criteria may apply