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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: 4-hydroxytamoxifen
* Procedure: breast imaging study
* Procedure: radiomammography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 4-hydroxytamoxifen|nan|
|Procedure: breast imaging study|nan|
|Procedure: radiomammography|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer