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

NCT00569543 | Completed

• 2 other identifiers: 0081-05-FBP30CA036727
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

breast cancer in situ; ductal breast carcinoma in situ; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women newly diagnosed with breast cancer that will be given tamoxifen or an aromatase inhibitor for therapeutic reasons.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Eppley Cancer Center at University of Nebraska Medical Center

Omaha, Nebraska, 68198-6805, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Interventions

Chromatography, High Pressure Liquid; Mass Spectrometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ercole Cavalieri, DSc

  Eppley Cancer Center at University of Nebraska Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 7, 2007
• Study Start: May 11, 2005
• Primary Completion: August 2, 2012
• Study Completion: August 2, 2012
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

US (2)