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

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT00084344
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
15
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

OBJECTIVES:

Primary

  • Determine the effect of 4-hydroxytamoxifen gel on breast density, as measured by digital mammography, in premenopausal women.

  • Determine the effect of this gel on breast density in these participants, as defined by the BIRADS lexicon.

Secondary

  • Determine the effect of this gel on salivary sex steroid levels in these participants.

  • Determine the effect of this gel on quality of life of these participants.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to 1 of 2 treatment arms.

  • Arm I: Participants apply 4-hydroxytamoxifen gel in 4 metered doses daily to each breast beginning on the first day after cessation of the first menstrual period after digital mammography is performed.

  • Arm II: Participants apply placebo gel as in arm I. In both arms, treatment continues for 1 year.

In both arms, participants collect daily saliva samples for 4 menstrual cycles during the study. Three of the saliva collections occur during the cycles encompassing the time periods when imaging studies are performed (months 0, 6, and 12). The fourth collection takes place during the first month that gel is applied to the breast.

Participants also undergo digital mammography at baseline, 6 months, and 1 year.

Participants who develop clinical breast problems considered suspicious for cancer discontinue study treatment until a histological diagnosis is established. Those found to have breast cancer are removed from the study and those with benign disease continue the study. If an excisional biopsy is performed, density measurements are made on the opposite breast.

Quality of life is assessed at baseline, 1 month, 6 months, and 1 year.

PROJECTED ACCRUAL: A total of 100 participants (50 per treatment arm) will be accrued for this study.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
Double
Primary Purpose:
Screening
Official Title:
A Prospective, Randomized, Placebo-Controlled Trial of the Effects of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women
Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Jul 1, 2004
Actual Study Completion Date :
Jul 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Seema A. Khan, MD, Robert H. Lurie Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Northwestern University
    ClinicalTrials.gov Identifier:
    NCT00084344
    Other Study ID Numbers:
    • NCI 00B3
    • NU-NCI-00B3
    • NU-3
    • NU-0365-011
    First Posted:
    Jun 11, 2004
    Last Update Posted:
    May 30, 2012
    Last Verified:
    May 1, 2012
    Keywords provided by Northwestern University
    breast cancer
    Additional relevant MeSH terms:
    Afimoxifene

    Study Results

    No Results Posted as of May 30, 2012