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Tracking Information | |||||
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First Received Date † | December 6, 2007 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | May 2005 | ||||
Current Primary Outcome Measures † |
Comparison of the estrogen compounds in urine before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00569543 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Effect of Tamoxifen or an Aromatase Inhibitor on Estrogen Metabolism in Women Undergoing Treatment for Newly Diagnosed Breast Cancer | ||||
Official Title † | Effects of Therapeutic Agents on Estrogens in the Breast | ||||
Brief Summary | RATIONALE: Studying samples of urine in the laboratory from women with breast cancer may help doctors learn whether tamoxifen and aromatase inhibitors alter the metabolism of estrogens. PURPOSE: This clinical trial is studying the effect of tamoxifen or an aromatase inhibitor on estrogen metabolism in women undergoing treatment for newly diagnosed breast cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: Patients are stratified according to planned therapy (tamoxifen citrate vs aromatase inhibitor). Patients receive tamoxifen citrate or an aromatase inhibitor as planned. Urine samples (and nipple aspirate fluid, if possible) are collected before beginning treatment and after 2-6 months of treatment. Samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultraperformance liquid chromatography with tandem mass spectrometric detection. Patients' information, including race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption, pregnancy history including age at each pregnancy, lactation, history of benign breast disease, hysterectomy, and disease type, is collected through medical record review. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Breast Cancer | ||||
Intervention † |
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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 † | Active, not recruiting | ||||
Enrollment † | 100 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2015 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Female | ||||
Ages | 19 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00569543 | ||||
Responsible Party | |||||
Secondary IDs †† | UNMC-08105 | ||||
Study Sponsor † | University of Nebraska | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |