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

Novartis

Status and phase: Completed; Phase 2

Conditions: Breast Neoplasm

Treatments: Drug: RAD001, Letrozole 2.5mg; Drug: Letrozole 2.5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00107016

CRAD001C2222

Details and patient eligibility

About

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.

Enrollment: 267 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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267 participants in 2 patient groups

RAD001 + letrozole 2.5mg

Experimental group

Treatment:

Drug: RAD001, Letrozole 2.5mg

Letrozole 2.5mg

Active Comparator group

Treatment:

Drug: Letrozole 2.5mg