Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention
Breast Cancer
Other: high performance liquid chromatography
Other: laboratory biomarker analysis
Other: mass spectrometry
Other: medical chart review

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Therapeutic Agents on Estrogens in the Breast

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Urine


Enrollment: 27
Study Start Date: May 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Ercole Cavalieri, DSc University of Nebraska
  More Information

Additional Information:
No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT00569543     History of Changes
Other Study ID Numbers: 081-05, P30CA036727, UNMC-08105
Study First Received: December 6, 2007
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Aromatase Inhibitors
Estrogens
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014