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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 6, 2007

Last Updated Date

February 6, 2009

Start Date ^†

May 2005

Current 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 [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00569543 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

Effects of Therapeutic Agents on Estrogens in the Breast

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.

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 Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Open Label

Condition ^†

Breast Cancer

Intervention ^†

Drug: aromatase inhibition therapy
Drug: tamoxifen citrate
Other: high performance liquid chromatography
Other: laboratory biomarker analysis
Other: mass spectrometry
Other: medical chart review

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

100

Completion Date

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Female

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00569543

Responsible Party

Secondary IDs ^††

UNMC-08105

Study Sponsor ^†

University of Nebraska

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

Ercole Cavalieri, DSc

University of Nebraska

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.