NCT00569543

Effect of Tamoxifen or an Aromatase Inhibitor on Estrogen Metabolism in Women Treated for Newly Diagnosed Breast Cancer

Effects of Therapeutic Agents on Estrogens in the Breast

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * 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

• Breast Cancer

Interventions

Type	Name	Description
OTHER	high performance liquid chromatography	urine analysis
OTHER	laboratory biomarker analysis	The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
OTHER	mass spectrometry	The urine samples will be analyzed for 40 estrogen metabolites, conjugates and depurinating DNA adducts by UPLC with tandem mass spectrometric detection.
OTHER	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.

Timeline

• Start date: 2005-05-11
• Primary completion: 2012-08-02
• Completion: 2012-08-02
• First posted: 2007-12-07
• Last updated: 2023-09-01

Locations

2 sites across 1 country: United States