Effect of Tamoxifen or an Aromatase Inhibitor on Estrogen Metabolism in Women Undergoing Treatment for Newly Diagnosed Breast Cancer
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.
|Breast Cancer||Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry Other: medical chart review|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effects of Therapeutic Agents on Estrogens in the Breast|
- Comparison of the estrogen compounds in urine [ Time Frame: before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||May 2005|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Other: high performance liquid chromatography
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569543
|United States, Minnesota|
|Mayo Clinic Cancer Center|
|Rochester, Minnesota, United States, 55905|
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Principal Investigator:||Ercole Cavalieri, DSc||University of Nebraska|