Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
- Conditions
- Breast Neoplasm
- Interventions
- Registration Number
- NCT00107016
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 267
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Letrozole 2.5mg Letrozole 2.5mg - RAD001 + letrozole 2.5mg RAD001, Letrozole 2.5mg -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method To assess the four month treatment as being predictive of clinical tumor response
Trial Locations
- Locations (11)
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
Breastlink Medical Group Inc.
🇺🇸Long Beach, California, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Novartis Investigative Site
🇬🇧Whittington, United Kingdom
University of Miami
🇺🇸Miami, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
UCSF Breast Care Center
🇺🇸San Francisco, California, United States
Investigative Clinical Research of Indiana
🇺🇸Indianapolis, Indiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
UPMC / Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States