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

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.

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