Trial Information

Sonographic Evaluation of the Effects of Raloxifene on the Uterus and Ovaries in Premenopausal Patients at High Risk for Developing Breast Cancer

Raloxifene is a selective estrogen receptor-modulating agent that has been recently approved
by the FDA for the treatment of osteoporosis in postmenopausal patients. A phase II trial
evaluating the safety and efficacy of raloxifene in premenopausal patients at high risk for
developing breast cancer has been recently approved by the IRB (98-C-0123). In this
protocol, for assessment of the effects of raloxifene on the endometrium and ovaries,
patients are scheduled to be studied with transvaginal sonography and hysterosonography,
once during their menstrual cycle at periodic intervals. They are also scheduled to have
endometrial biopsies as indicated. It is known that all SERMs (clomiphene, tamoxifen and in
one small study raloxifene) raise the area under the curve of estradiol levels throughout
the cycle in premenopausal women. Our study is designed to study the reproductive effects
of raloxifene in these young women with competent ovaries using sonography of the ovaries
and endometrium, and correlating it with steroid hormone levels which would be obtained
under protocol 98-C-0123.