Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

Inclusion Criteria: * Patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy * Histological or cytological confirmation of ER+/ 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 had received prior hormonal or any other systemic therapy for metastatic breast cancer. Patients might 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 might apply