Breast Cancer
Conditions
Keywords
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
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.
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.
Interventions
OTHERhigh performance liquid chromatography
urine analysis
OTHERlaboratory biomarker analysis
The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
OTHERmass spectrometry
The urine samples will be analyzed for 40 estrogen metabolites, conjugates and depurinating DNA adducts by UPLC with tandem mass spectrometric detection.
OTHERmedical 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.
Sponsors
National Cancer Institute (NCI)
University of Nebraska
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of estrogen compounds in urine | before and after treatment for two-to-six months | Comparison of estrogen compounds in urine before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months |
Countries
United States
Outcome results
None listed