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

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ClinicalTrials.gov Identifier: NCT00107016
Recruitment Status : Completed
First Posted : April 5, 2005
Last Update Posted : March 4, 2013
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: RAD001, Letrozole 2.5mg Drug: Letrozole 2.5mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2005
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: RAD001 + letrozole 2.5mg Drug: RAD001, Letrozole 2.5mg
Active Comparator: Letrozole 2.5mg Drug: Letrozole 2.5mg

Primary Outcome Measures :
  1. 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 :
  1. To assess the four month treatment as being predictive of clinical tumor response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107016

  Hide Study Locations
United States, Arkansas
Highlands Oncology Group
Springdale, Arkansas, United States, 72764
United States, California
Breastlink Medical Group Inc.
Long Beach, California, United States, 90806
UCSF Breast Care Center
San Francisco, California, United States, 94115
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States, 46254
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Pennsylvania
UPMC / Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Vienna, Austria
Novartis Investigative Site
Wilrijk, Belgium
Novartis Investigative Site
Natasha, Canada
Novartis Investigative Site
Winnipeg, Canada
Novartis Investigative Site
Besancon, France
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Montpellier, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Saint-Herblain, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Erlangen, Germany
Novartis Investigative Site
Frankurt am Main, Germany
Novartis Investigative Site
Jena, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Muenchen, Germany
Novartis Investigative Site
Regensburg, Germany
Novartis Investigative Site
Tuebingen, Germany
Novartis Investigative Site
Florence, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Naples, Italy
Novartis Investigative Site
Torino, Italy
Russian Federation
Novartis Investigative Site
Cheliabinsk, Russian Federation
Novartis Investigative Site
Kazan, Russian Federation
Novartis Investigative Site
Saint Petersburg, Russian Federation
Novartis Investigative Site
St Petersburg, Russian Federation
Novartis Investigative Site
Alicante, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Cordoba, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative Site
Zaragoza, Spain
United Kingdom
Novartis Investigative Site
Chelmsford, United Kingdom
Novartis Investigative Site
Edinburgh, United Kingdom
Novartis Investigative Site
Epping, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Whittington, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00107016     History of Changes
Other Study ID Numbers: CRAD001C2222
First Posted: April 5, 2005    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast Cancer
Cancer of the Breast
Primary breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents