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OpenTrials
Completed

NCT Number: NCT00569543

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

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.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • ECOG performance status 0, 1, or 2

Exclusion criteria

  • Not pregnant or nursing
  • No prior antiestrogen drug such as tamoxifen citrate or raloxifene
  • No concurrent estrogens

Treatment and study plan

high performance liquid chromatography

Other

urine analysis

laboratory biomarker analysis

Other

The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.

mass spectrometry

Other

The urine samples will be analyzed for 40 estrogen metabolites, conjugates and depurinating DNA adducts by UPLC with tandem mass spectrometric detection.

medical chart review

Other

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 outcomes

  1. Comparison of estrogen compounds in urine

    Time frame: before and after treatment for two-to-six months

    Comparison of estrogen compounds in urine before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Effects of Therapeutic Agents on Estrogens in the Breast

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Dec 7, 2007
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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