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Tracking Information | |||||
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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 † |
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Original Secondary Outcome Measures † |
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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. |
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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. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 263 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion criteria
Exclusion criteria
Patients with endometrial cancer at any time in their medical history are excluded. |
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Gender | Female | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Denmark | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00171704 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Novartis | ||||
Collaborators †† |
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Investigators † |
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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. |