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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569543
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : May 15, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Nebraska

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.

Condition or disease Intervention/treatment
Breast Cancer Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry Other: medical chart review

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Therapeutic Agents on Estrogens in the Breast
Study Start Date : May 2005
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Estrogens

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women newly diagnosed with breast cancer that will be given tamoxifen or an aromatase inhibitor for therapeutic reasons.


  • 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


  • Menopausal status not specified
  • ECOG performance status 0, 1, or 2
  • Not pregnant or nursing


  • No prior antiestrogen drug such as tamoxifen citrate or raloxifene
  • No concurrent estrogens

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569543

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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
Sponsors and Collaborators
University of Nebraska
National Cancer Institute (NCI)
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Principal Investigator: Ercole Cavalieri, DSc University of Nebraska

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Responsible Party: University of Nebraska Identifier: NCT00569543     History of Changes
Other Study ID Numbers: 081-05
P30CA036727 ( U.S. NIH Grant/Contract )
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013
Keywords provided by University of Nebraska:
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs