Breast Cancer Survivors: Exercise and Raloxifene

OBJECTIVES:

• Determine the effects of raloxifene with or without exercise versus exercise alone on bone reabsorption rate, bone formation rate, and bone density in women previously treated for breast cancer.
• Determine the effects of these regimens on the quality of life of these patients.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are randomized to one of four treatment arms.

• Arm I: Patients are asked to exercise 5 days a week with instruction. Patients also receive oral placebo once daily.
• Arm II: Patients receive oral raloxifene once daily.
• Arm III: Patients are asked to exercise as in arm I. Patients also receive oral raloxifene once daily.
• Arm IV: Patients receive oral placebo once daily. All patients receive oral calcium supplements once daily. Treatment continues in all arms for 24 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and every 3 months during study.