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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00107016
First received: April 4, 2005
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Breast Neoplasm
Drug: RAD001, Letrozole 2.5mg
Drug: Letrozole 2.5mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Enrollment: 267
Study Start Date: March 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 + letrozole 2.5mg Drug: RAD001, Letrozole 2.5mg
Active Comparator: Letrozole 2.5mg Drug: Letrozole 2.5mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107016

  Hide Study Locations
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
Austria
Novartis Investigative Site
Salzburg, Austria
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Vienna, Austria
Belgium
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Wilrijk, Belgium
Canada
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Natasha, Canada
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Winnipeg, Canada
France
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Besancon, France
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Bordeaux, France
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Montpellier, France
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Paris, France
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Saint-Herblain, France
Germany
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Berlin, Germany
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Erlangen, Germany
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Frankurt am Main, Germany
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Jena, Germany
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Kiel, Germany
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Muenchen, Germany
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Regensburg, Germany
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Tuebingen, Germany
Italy
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Florence, Italy
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Milan, Italy
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Naples, Italy
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Torino, Italy
Russian Federation
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Cheliabinsk, Russian Federation
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Kazan, Russian Federation
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Saint Petersburg, Russian Federation
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St Petersburg, Russian Federation
Spain
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Alicante, Spain
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Barcelona, Spain
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Cordoba, Spain
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Madrid, Spain
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Valencia, Spain
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Zaragoza, Spain
United Kingdom
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Chelmsford, United Kingdom
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Edinburgh, United Kingdom
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Epping, United Kingdom
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London, United Kingdom
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Whittington, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00107016     History of Changes
Other Study ID Numbers: CRAD001C2222
Study First Received: April 4, 2005
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Breast Cancer
Cancer of the Breast
Neo-adjuvant
Primary breast cancer
postmenopausal
pre-operative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Everolimus
Letrozole
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014