Effect of Tamoxifen or an Aromatase Inhibitor on Estrogen Metabolism in Women Treated for Newly Diagnosed Breast Cancer
NCT ID: NCT00569543
Last Updated: 2023-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
27 participants
OBSERVATIONAL
2005-05-11
2012-08-02
Brief Summary
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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
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* Learn the effects of selected chemotherapy agents on the profile of estrogen metabolites, glutathione conjugates, and depurinating DNA adducts in urine from women with breast cancer.
* Determine whether tamoxifen citrate or aromatase inhibitor alters the metabolism of estrogens.
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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high performance liquid chromatography
urine analysis
laboratory biomarker analysis
The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
mass spectrometry
The urine samples will be analyzed for 40 estrogen metabolites, conjugates and depurinating DNA adducts by UPLC with tandem mass spectrometric detection.
medical chart review
Collection of information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to receive tamoxifen citrate or an aromatase inhibitor
* Estrogen receptor or progesterone receptor positive
* ECOG performance status 0, 1, or 2
Exclusion Criteria
* No prior antiestrogen drug such as tamoxifen citrate or raloxifene
* No concurrent estrogens
19 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Ercole Cavalieri, DSc
Role: PRINCIPAL_INVESTIGATOR
Eppley Cancer Center at University of Nebraska Medical Center
Locations
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Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Eppley Cancer Center at University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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Other Identifiers
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0081-05-FB
Identifier Type: -
Identifier Source: org_study_id
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