Trial Information

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

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.