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 clinical 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 as defined above.

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,

Other protocol-defined inclusion/exclusion criteria may apply