Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
NCT ID: NCT00107016
Last Updated: 2013-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
267 participants
INTERVENTIONAL
2005-03-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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RAD001 + letrozole 2.5mg
RAD001, Letrozole 2.5mg
Letrozole 2.5mg
Letrozole 2.5mg
Interventions
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RAD001, Letrozole 2.5mg
Letrozole 2.5mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Highlands Oncology Group
Springdale, Arkansas, United States
Breastlink Medical Group Inc.
Long Beach, California, United States
UCSF Breast Care Center
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Loyola University Medical Center
Maywood, Illinois, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
UPMC / Magee Womens Hospital
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Salzburg, , Austria
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Vienna, , Austria
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Wilrijk, , Belgium
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Natasha, , Canada
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Winnipeg, , Canada
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Besançon, , 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
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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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München, , Germany
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Regensburg, , Germany
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Tübingen, , Germany
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Florence, , Italy
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Milan, , Italy
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Naples, , Italy
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Torino, , Italy
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Chelyabinsk, , Russia
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Kazan', , Russia
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Saint Petersburg, , Russia
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Alicante, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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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
Countries
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References
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Baselga J, Semiglazov V, van Dam P, Manikhas A, Bellet M, Mayordomo J, Campone M, Kubista E, Greil R, Bianchi G, Steinseifer J, Molloy B, Tokaji E, Gardner H, Phillips P, Stumm M, Lane HA, Dixon JM, Jonat W, Rugo HS. Phase II randomized study of neoadjuvant everolimus plus letrozole compared with placebo plus letrozole in patients with estrogen receptor-positive breast cancer. J Clin Oncol. 2009 Jun 1;27(16):2630-7. doi: 10.1200/JCO.2008.18.8391. Epub 2009 Apr 20.
Other Identifiers
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CRAD001C2222
Identifier Type: -
Identifier Source: org_study_id
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