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

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ClinicalTrials.gov Identifier: NCT00569543
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : May 15, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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:

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.


Study Design

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
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

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
Urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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.
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

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 ClinicalTrials.gov identifier (NCT number): NCT00569543


Locations
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)
Investigators
Principal Investigator: Ercole Cavalieri, DSc University of Nebraska
More Information

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT00569543     History of Changes
Other Study ID Numbers: 081-05
P30CA036727 ( U.S. NIH Grant/Contract )
UNMC-08105
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Aromatase Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists