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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Letrozole; Sirolimus

Criteria

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.