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

February 28, 2013 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria
        • Novartis Investigative Site
      • Vienna, Austria
        • Novartis Investigative Site
  • Belgium
      • Wilrijk, Belgium
        • Novartis Investigative Site
  • Canada
      • Natasha, Canada
        • Novartis Investigative Site
      • Winnipeg, Canada
        • Novartis Investigative Site
  • France
      • 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
  • Germany
      • 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
  • Italy
      • Florence, Italy
        • Novartis Investigative Site
      • Milan, Italy
        • Novartis Investigative Site
      • Naples, Italy
        • Novartis Investigative Site
      • Torino, Italy
        • Novartis Investigative Site
  • Russian Federation
      • 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
  • Spain
      • 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
        • Novartis Investigative Site
  • United Kingdom
      • 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
        • Novartis Investigative Site
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • California
      • Long Beach, California, United States, 90806
        • Breastlink Medical Group Inc.
      • San Francisco, California, United States, 94115
        • UCSF Breast Care Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Investigative Clinical Research of Indiana
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC / Magee Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAD001 + letrozole 2.5mg
Drug: RAD001, Letrozole 2.5mg
Active Comparator: Letrozole 2.5mg
Drug: Letrozole 2.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
To assess the four month treatment as being predictive of clinical tumor response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

April 4, 2005

First Submitted That Met QC Criteria

April 4, 2005

First Posted (Estimate)

April 5, 2005

Study Record Updates

Last Update Posted (Estimate)

March 4, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001C2222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe