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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00569543
First received: December 6, 2007
Last updated: May 14, 2013
Last verified: May 2013

December 6, 2007
May 14, 2013
May 2005
August 2012   (final data collection date for primary outcome measure)
Comparison of the estrogen compounds in urine [ Time Frame: before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months ] [ Designated as safety issue: No ]
Comparison of the estrogen compounds in urine before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months
Complete list of historical versions of study NCT00569543 on ClinicalTrials.gov Archive Site
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Effect of Tamoxifen or an Aromatase Inhibitor on Estrogen Metabolism in Women Undergoing Treatment for Newly Diagnosed Breast Cancer
Effects of Therapeutic Agents on Estrogens in the Breast

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Urine

Non-Probability Sample

Women newly diagnosed with breast cancer that will be given tamoxifen or an aromatase inhibitor for therapeutic reasons.

Breast Cancer
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Female
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00569543
081-05, P30CA036727, UNMC-08105
No
University of Nebraska
University of Nebraska
National Cancer Institute (NCI)
Principal Investigator: Ercole Cavalieri, DSc University of Nebraska
University of Nebraska
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP