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

NCT00171704 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2017-03-03

Study results available
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Summary

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

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

Conditions

  • Hormone Sensitive Resected Primary Breast Cancer in Postmenopausal Women

Interventions

DRUG

Letrozole

2.5 mg tablets and supplied in bottles with 6-monthly supplies.

DRUG

Tamoxifen

20 mg tablets in bottles as 6-monthly supplies (supplied to Novartis as Tamofen from Schering Oy, Subsidiary of Schering AG, Pansiontie 47, FIN-2010 Turku, Finland)

Sponsors & Collaborators

  • Danish Breast Cancer Cooperative Group

    collaborator OTHER

  • University of Sheffield

    collaborator OTHER

  • Novartis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Denmark
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00171704 on ClinicalTrials.gov