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