Everolimus and Letrozole as Preoperative Therapy of Primary Breast Cancer in Post-menopausal Women
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
1 other identifier
interventional
267
10 countries
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2005
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 4, 2005
CompletedFirst Posted
Study publicly available on registry
April 5, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMarch 4, 2013
February 1, 2013
2.1 years
April 4, 2005
February 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (1)
To assess the four month treatment as being predictive of clinical tumor response
Study Arms (2)
RAD001 + letrozole 2.5mg
EXPERIMENTALLetrozole 2.5mg
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Highlands Oncology Group
Springdale, Arkansas, 72764, United States
Breastlink Medical Group Inc.
Long Beach, California, 90806, United States
UCSF Breast Care Center
San Francisco, California, 94115, United States
University of Miami
Miami, Florida, 33136, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Investigative Clinical Research of Indiana
Indianapolis, Indiana, 46254, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
UPMC / Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, 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
Related Publications (1)
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.
PMID: 19380449DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2005
First Posted
April 5, 2005
Study Start
March 1, 2005
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
March 4, 2013
Record last verified: 2013-02