A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
A Prospective Study Of The Effect Of Tamoxifen On Breast Density In Premenopausal Women
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.
OBJECTIVES:
Primary
Secondary
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.
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:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Premenopausal
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Not pregnant or nursing
No medical or psychiatric disorder that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery