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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

September 6, 2007

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Percent change from baseline in lumbar spine (L2-L4) BMD at 2 years

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00171704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Evaluate the effect of long-term use
Safety
Efficacy

Original Secondary Outcome Measures ^†

Evaluate the effect of long-term use
Safety
Efficacy

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study

Condition ^†

Hormone Sensitive Resected Primary Breast Cancer in Postmenopausal Women.

Intervention ^†

Drug: Letrozole

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

263

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion criteria

Female sex.
Postmenopausal
Histologically confirmed resected breast cancer AND eligible for adjuvant endocrine therapy.
Life expectancy of at least 24 months.

Exclusion criteria

Patients with distant metastases.
Pre-existing bone disease
Patients receiving bisphosphonates for more than 3 months before randomization.
Chronic treatment with drugs known to interfere with bone metabolism.
Treatment with lipid lowering agents within the 3 months prior to randomization.
Patient receiving other anti-cancer treatment.
Previous neoadjuvant / adjuvant chemotherapy.
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.

Gender

Female

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00171704

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Danish Breast Cancer Cooperative Group
University of Sheffield

Investigators ^†

Study Chair:

Novartis

Information Provided By

Novartis

Verification Date

September 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.