Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women

Inclusion Criteria: * Histologically-confirmed diagnosis of invasive breast cancer, previously untreated * Patients must be postmenopausal * Candidates for mastectomy or breast-conserving surgery * Primary tumor of above 2 cm diameter, measured by imaging * Clinical Stage M0 * WHO performance status ≤1 * Adequate bone marrow, liver, and renal function Exclusion Criteria: * Multicentric invasive tumors * Bilateral or inflammatory breast cancer * Receiving concomitant anti-cancer treatments such as chemotherapy * Patients with an uncontrolled infection * Patients with other concurrent severe and/or uncontrolled medical disease Additional protocol-defined inclusion/exclusion criteria may apply.