Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer

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. Tamoxifen may be effective in reducing breast density by decreasing estrogen levels. PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer.

Detailed Description
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OBJECTIVES: Primary Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction. Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug. Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug. Secondary Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients. Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug. OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction). Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion. PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Official Title
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A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast cancer risk reduction Undergoing mammography at least annually No bilateral breast cancer or stage IV breast cancer Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 20 to 45 Sex Female Menopausal status Premenopausal No change in menstrual patterns within the past 6 months Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant or nursing No planned pregnancy within the next 5 years No medical or psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for breast cancer Endocrine therapy See Disease Characteristics No prior tamoxifen for more than 1 month in duration Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tamoxifen group<br> | |

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, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer