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

Breast Cancer Clinical Trial

Official title:

Effects of Therapeutic Agents on Estrogens in the Breast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569543
• Other study ID #: 0081-05-FB
• Secondary ID: P30CA036727
• Status: Completed
• Start date: May 11, 2005
• Est. completion date: August 2, 2012

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2, 2012
• Est. primary completion date: August 2, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• high performance liquid chromatography
urine analysis
• laboratory biomarker analysis
The biomarkers of interest will be the metabolites 4-OHE1(E2), estrogen-GSH conjugates and depurinating estrogen-DNA adducts.
• mass spectrometry
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
Collection of information about age, race, general health, any endocrine disorders, history of cancer, estrogen and progesterone receptor status, menopausal status and breast disease.

Locations

Country	Name	City	State
United States	Eppley Cancer Center at University of Nebraska Medical Center	Omaha	Nebraska
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of estrogen compounds in urine	Comparison of estrogen compounds in urine before and after treatment with tamoxifen or an aromatase inhibitor for two-to-six months	before and after treatment for two-to-six months