Effect of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women
Condition: Breast Cancer
Study type: Interventional

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.
    

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.
    

Intervention name(s): 4-hydroxytamoxifen; breast imaging study; radiomammography
Intervention type(s): Drug; Procedure; Procedure
Intervention MeSH terms: Afimoxifene
Allocation: Randomized
Masking: Double
Primary purpose: Screening
Keywords: breast cancer