Breast Cancer Clinical Trial
Official title:
Estrogen-DNA Adducts in Breast, Urine and Serum as Biomarkers of Breast Cancer Risk
RATIONALE: Studying samples of nipple fluid, urine, and blood in the laboratory from patients
with cancer and from patients at risk of developing cancer may help doctors identify and
learn more about biomarkers related to cancer. It may also help doctors learn more about
breast cancer and identify patients at risk of developing breast cancer.
PURPOSE: This laboratory study is looking at biomarkers in nipple fluid, urine, and blood
samples from women with newly diagnosed ductal carcinoma in situ or stage I or stage II
breast cancer and in women at risk of developing breast cancer.
OBJECTIVES:
- To determine the levels of catechol estrogens (CE), CE metabolites, CE-DNA adducts, and
CE conjugates in nipple aspirate fluid samples obtained from women with newly diagnosed
ductal carcinoma in situ or stage I or II breast cancer and from women at high risk of
developing breast cancer.
OUTLINE: Patients with newly diagnosed breast cancer or at high risk of developing breast
cancer undergo nipple aspiration. The nipple aspirate fluid is obtained from the unaffected
breast and is analyzed for 31 estrogen metabolites, conjugates, and depurinating DNA adducts
by high-performance liquid chromatography (LC) with electrochemical and mass spectrometric
detectors. All patients undergo urine and serum sample collection. The urine samples are
analyzed by ultraperformance LC monitored by tandem mass spectrometry for estrogen
metabolites, conjugates, and depurinating DNA adducts.
Patients' charts are reviewed to obtain information about age, race, general health, any
endocrine disorders, history of cancer, estrogen and progesterone receptor status, and
HER2/neu status (for patients with newly diagnosed breast cancer), menopausal status,
reproductive history, history of breast disease, medication use, smoking history, and history
of alcohol consumption.
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