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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00107016
Recruitment Status : Completed
First Posted : April 5, 2005
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : March 2005
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. To assess the four month treatment as being predictive of clinical tumor response

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107016


  Show 47 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00107016     History of Changes
Other Study ID Numbers: CRAD001C2222
First Posted: April 5, 2005    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: February 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast Cancer
Cancer of the Breast
Neo-adjuvant
Primary breast cancer
postmenopausal
pre-operative

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents