An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Metastatic Breast Cancer

Inclusion Criteria:

- Patients 18 years old or greater

- Patients with metastatic or locally advanced, unresectable breast cancer not amenable
to curative treatment by surgery or radiotherapy

- Histological or cytological confirmation of estrogen-receptor positive (ER+) human
epidermal growth factor receptor 2 negative (HER2-) breast cancer

- Postmenopausal women

- No prior treatment for metastatic breast cancer

Exclusion Criteria:

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

- Patients who have received prior hormonal or any other systemic therapy for
metastatic breast cancer.

- Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the
case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must
have completed therapy at least 1 year prior to study enrollment.

- Previous treatment with mTOR inhibitors.

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

- Other protocol-defined inclusion/exclusion criteria may apply