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

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT00569543

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

13.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry Other: medical chart review

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.

Study Design

Study Type:

Observational

Actual Enrollment :

27 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effects of Therapeutic Agents on Estrogens in the Breast

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
2	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-6805