Clinical Trials (PDQ®) - National Cancer Institute

Page Options

	Quick Links


	Director's Corner Dictionary of Cancer Terms NCI Drug Dictionary Funding Opportunities NCI Publications Advisory Boards and Groups Science Serving People Español

Questions about cancer?


	1-800-4-CANCER

	LiveHelp online chat

	NCI Highlights


	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Completed 50 and over Pharmaceutical / Industry CFEM345D2407
NCT00171704

Trial Description

Summary

Estrogen is known to be a regulator of bone and lipid metabolism. Letrozole is a potent inhibitor of estrogen synthesis.

This study will evaluate the effects of letrozole and tamoxifen on bone and lipid metabolism in postmenopausal women with resected, receptor positive early breast cancer.

Eligibility Criteria

Inclusion criteria

1. Female sex.

2. Postmenopausal

3. Histologically confirmed resected breast cancer AND eligible for adjuvant endocrine therapy.

4. Life expectancy of at least 24 months.

Exclusion criteria

1. Patients with distant metastases.

2. Pre-existing bone disease

3. Patients receiving bisphosphonates for more than 3 months before randomization.

4. Chronic treatment with drugs known to interfere with bone metabolism.

5. Treatment with lipid lowering agents within the 3 months prior to randomization.

6. Patient receiving other anti-cancer treatment.

7. Previous neoadjuvant / adjuvant chemotherapy.

8. History of previous or concomitant other (not breast cancer) malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for five years.

Patients with endometrial cancer at any time in their medical history are excluded.

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

Danish Breast Cancer Cooperative Group

University of Sheffield

Novartis

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00171704
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.