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
Data Collection
Screening Study
Summary
Study start date: April 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Screening Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 30 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesSee the location