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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: April 4, 2005
Last updated: February 28, 2013
Last verified: February 2013
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 Intervention Phase
Breast Neoplasm Drug: RAD001, Letrozole 2.5mg Drug: Letrozole 2.5mg Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Enrollment: 267
Study Start Date: March 2005
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 + letrozole 2.5mg Drug: RAD001, Letrozole 2.5mg
Active Comparator: Letrozole 2.5mg Drug: Letrozole 2.5mg


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00107016

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00107016     History of Changes
Other Study ID Numbers: CRAD001C2222
Study First Received: April 4, 2005
Last Updated: February 28, 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast Cancer
Cancer of the Breast
Primary breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
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 processed this record on August 18, 2017