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

NCT00569543 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2023-09-01

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Ercole Cavalieri, DSc · Eppley Cancer Center at University of Nebraska Medical Center

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-11
Primary Completion
2012-08-02
Completion
2012-08-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00569543 on ClinicalTrials.gov