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

Breast Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107016
• Other study ID #: CRAD001C2222
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2005
• Last updated: February 28, 2013
• Start date: March 2005
• Est. completion date: April 2007

Study information

• Verified date: February 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• RAD001, Letrozole 2.5mg

• Letrozole 2.5mg

Locations

Country	Name	City	State
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Vienna
Belgium	Novartis Investigative Site	Wilrijk
Canada	Novartis Investigative Site	Natasha
Canada	Novartis Investigative Site	Winnipeg
France	Novartis Investigative Site	Besancon
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Saint-Herblain
Germany	Novartis Investigative Site	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
Italy	Novartis Investigative Site	Florence
Italy	Novartis Investigative Site	Milan
Italy	Novartis Investigative Site	Naples
Italy	Novartis Investigative Site	Torino
Russian Federation	Novartis Investigative Site	Cheliabinsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	St Petersburg
Spain	Novartis Investigative Site	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
United Kingdom	Novartis Investigative Site	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 States	University of Michigan	Ann Arbor	Michigan
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Investigative Clinical Research of Indiana	Indianapolis	Indiana
United States	Breastlink Medical Group Inc.	Long Beach	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	UPMC / Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	UCSF Breast Care Center	San Francisco	California
United States	Highlands Oncology Group	Springdale	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the four month treatment as being predictive of clinical tumor response