A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
- Compare the feasibility of raloxifene and goserelin versus no medical intervention in
women at high genetic risk for developing breast cancer.
- Compare the incidence of adverse effects in patients treated with these regimens.
- Compare the effect of these regimens on bone density, biochemical markers of bone
turnover, and lipid profiles in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene
daily for 6-12 months.
- Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients
undergo annual mammograms.
Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this
Primary Purpose: Prevention
Anthony Howell, MD
Christie Hospital NHS Foundation Trust
United States: Federal Government