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: November 2, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 4, 2005

Last Updated Date

November 2, 2011

Start Date ^ICMJE

March 2005

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

increased clinical tumor response rates
predictor of clinical tumor response

Change History

Complete list of historical versions of study NCT00107016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

safety and tolerability of the treatment regimens
correlation of tumor volume to biological marker expression
comparison of breast-conserving surgery versus mastectomy
comparison of frequency of pathological response
investigation of letrozole pharmacokinetics
investigation of tumor-specific mutations

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Condition ^ICMJE

Breast Neoplasm

Intervention ^ICMJE

Drug: RAD001, Letrozole 2.5mg
Drug: Letrozole 2.5mg

Study Arm (s)

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

Publications *

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. Epub 2009 Apr 20.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

255

Completion Date

December 2007

Primary Completion Date

April 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, Canada, France, Germany, Italy, Russian Federation, Spain, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00107016

Other Study ID Numbers ^ICMJE

CRAD001C2222

Has Data Monitoring Committee

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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