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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084344 |
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 | Intervention |
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Breast Cancer |
Drug: 4-hydroxytamoxifen Procedure: breast imaging study Procedure: mammography |
Study Type: | Interventional |
Study Design: | Screening, Randomized, Double-Blind, Placebo Control |
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: | April 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | 30 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Seema A. Khan, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000346461, NU-NCI-00B3, NU-3, NU-0365-011 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00084344 |
Health Authority: | United States: Federal Government |
breast cancer |
4-hydroxytamoxifen Skin Diseases Quality of Life |
Breast Neoplasms Tamoxifen Breast Diseases |
Estrogen Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |