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

A Phase 2, Double-blind, Randomized, Placebo-controlled, Multi-center Study Assessing the Value of Adding Everolimus to Letrozole as Preoperative Therapy of Primary Breast Cancer in Postmenopausal Women

The purpose of this study is to examine the effect of the combination of everolimus and letrozole compared to placebo and letrozole as pre-surgical therapy in patients with newly diagnosed estrogen receptor positive breast cancer.

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.