Effect of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women

NCT00084344 | Completed DMC

• 4 other identifiers: NCI 00B3NU-NCI-00B3NU-3NU-0365-011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. 4-hydroxytamoxifen gel (a substance made when tamoxifen breaks down in the body) may be effective in reducing breast density by reducing estrogen levels with fewer side effects than tamoxifen. This may improve quality of life and the ability to detect breast cancer with screening mammography. PURPOSE: Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on breast density, salivary sex steroids (hormones), and quality of life in premenopausal women.

Conditions

Breast Cancer

Keywords

breast cancer

Interventions

4-hydroxytamoxifen DRUG

breast imaging study PROCEDURE

radiomammography PROCEDURE

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Premenopausal as determined by a menstrual history of no change in menstrual pattern within the past 6 months * Undergoing mammography at least annually * No prior breast cancer * No clinical breast abnormalities suspicious for cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 30 to 50 Sex * Female Menopausal status * See Disease Characteristics Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective barrier contraception * No medical or psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 3 months since prior oral contraceptives or other estrogen- or progesterone-containing drugs * No prior tamoxifen for more than 1 month duration * No concurrent oral contraceptives or other estrogen- or progesterone-containing drugs * No other concurrent antiestrogen medications Radiotherapy * Not specified Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

afimoxifene

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seema A. Khan, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SCREENING
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: April 1, 2003
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: May 30, 2012

Record last verified: 2012-05

Locations

US (1)