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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Therapeutic Agents on Estrogens in the Breast

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: high performance liquid chromatography
* Other: laboratory biomarker analysis
* Other: mass spectrometry
* Other: medical chart review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed ductal carcinoma in situ or invasive breast cancer Scheduled to receive tamoxifen citrate or an aromatase inhibitor Estrogen receptor or progesterone receptor positive ECOG performance status 0, 1, or 2 Exclusion Criteria: Not pregnant or nursing No prior antiestrogen drug such as tamoxifen citrate or raloxifene No concurrent estrogens

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of estrogen compounds in urine | Comparison of estrogen compounds in urine before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months | before and after treatment for two-to-six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer in situ, ductal breast carcinoma in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer