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

Novartis Pharmaceuticals11 sites in 2 countries267 target enrollmentMarch 2005

ConditionsBreast Neoplasm

InterventionsRAD001, Letrozole 2.5mg Letrozole 2.5mg

DrugsRAD001, Letrozole 2.5mg Letrozole 2.5mg

Overview

Phase: Phase 2
Intervention: RAD001, Letrozole 2.5mg
Conditions: Breast Neoplasm
Sponsor: Novartis Pharmaceuticals
Enrollment: 267
Locations: 11
Primary Endpoint: To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2005

End Date

April 2007

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

RAD001 + letrozole 2.5mg

Intervention: RAD001, Letrozole 2.5mg

Letrozole 2.5mg

Intervention: Letrozole 2.5mg

Outcomes

Primary Outcomes

To assess the added efficacy obtained by combining RAD001 and letrozole as preoperative therapy for four months in hormone-receptor positive breast cancer in postmenopausal women