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

This study has been completed.

Sponsors and Collaborators:	Novartis Danish Breast Cancer Cooperative Group University of Sheffield
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171704

Purpose

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.

Condition	Intervention	Phase
Hormone Sensitive Resected Primary Breast Cancer in Postmenopausal Women.	Drug: Letrozole	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Letrozole Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety Study
Official Title:	A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Evaluate the effect of long-term use
Safety
Efficacy

Estimated Enrollment:	263
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171704

Locations

Denmark
Onkologisk Afd 5072, H:S Rigshospitalet
Copenhagen, Denmark

Sponsors and Collaborators

Novartis

Danish Breast Cancer Cooperative Group

University of Sheffield

Investigators

Study Chair:

Novartis

More Information

Study ID Numbers:	CFEM345D2407
Study First Received:	September 13, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00171704
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Novartis:

Breast Cancer
Letrozole
Bone Mineral Density

Bone Markers
Serum lipid
Postmenopausal

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Tamoxifen
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009