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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00107016

Collaborator

(none)

267

Enrollment

Locations

Arms

Duration (Months)

5.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm	Drug: RAD001, Letrozole 2.5mg Drug: Letrozole 2.5mg	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

267 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: RAD001 + letrozole 2.5mg

Drug: RAD001, Letrozole 2.5mg

Active Comparator: Letrozole 2.5mg

Drug: Letrozole 2.5mg

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Highlands Oncology Group	Springdale	Arkansas	United States	72764
2	Breastlink Medical Group Inc.	Long Beach	California	United States	90806
3	UCSF Breast Care Center	San Francisco	California	United States	94115
4	University of Miami	Miami	Florida	United States	33136
5	Loyola University Medical Center	Maywood	Illinois	United States	60153
6	Investigative Clinical Research of Indiana	Indianapolis	Indiana	United States	46254
7	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
8	University of Michigan	Ann Arbor	Michigan	United States	48109
9	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
10	UPMC / Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213
11	Novartis Investigative Site	Salzburg		Austria
12	Novartis Investigative Site	Vienna		Austria
13	Novartis Investigative Site	Wilrijk		Belgium
14	Novartis Investigative Site	Natasha		Canada
15	Novartis Investigative Site	Winnipeg		Canada
16	Novartis Investigative Site	Besancon		France
17	Novartis Investigative Site	Bordeaux		France
18	Novartis Investigative Site	Montpellier		France
19	Novartis Investigative Site	Paris		France
20	Novartis Investigative Site	Saint-Herblain		France
21	Novartis Investigative Site	Berlin		Germany
22	Novartis Investigative Site	Erlangen		Germany
23	Novartis Investigative Site	Frankurt am Main		Germany
24	Novartis Investigative Site	Jena		Germany
25	Novartis Investigative Site	Kiel		Germany
26	Novartis Investigative Site	Muenchen		Germany
27	Novartis Investigative Site	Regensburg		Germany
28	Novartis Investigative Site	Tuebingen		Germany
29	Novartis Investigative Site	Florence		Italy
30	Novartis Investigative Site	Milan		Italy
31	Novartis Investigative Site	Naples		Italy
32	Novartis Investigative Site	Torino		Italy
33	Novartis Investigative Site	Cheliabinsk		Russian Federation
34	Novartis Investigative Site	Kazan		Russian Federation
35	Novartis Investigative Site	Saint Petersburg		Russian Federation
36	Novartis Investigative Site	St Petersburg		Russian Federation
37	Novartis Investigative Site	Alicante		Spain
38	Novartis Investigative Site	Barcelona		Spain
39	Novartis Investigative Site	Cordoba		Spain
40	Novartis Investigative Site	Madrid		Spain
41	Novartis Investigative Site	Valencia		Spain
42	Novartis Investigative Site	Zaragoza		Spain
43	Novartis Investigative Site	Chelmsford		United Kingdom
44	Novartis Investigative Site	Edinburgh		United Kingdom
45	Novartis Investigative Site	Epping		United Kingdom
46	Novartis Investigative Site	London		United Kingdom
47	Novartis Investigative Site	Whittington		United Kingdom