Study Confirms Raloxifene Protects Post-Menopausal Women From Invasive Disease.(invasive breast cancer)

2001 MAR 8 - (NewsRx.com) -- The drug raloxifene significantly reduces the risk of invasive breast cancer in post-menopausal women, according to results of a large-scale study published in the journal Breast Cancer Research and Treatment.

The Multiple Outcomes of Raloxifene Evaluation (MORE) trial measured the effects of raloxifene, which has been approved by the U.S. Food and Drug Administration for the prevention and treatment of osteoporosis, on breast cancer rates after four years of follow-up. The results confirm the study's preliminary findings, which where published in the Journal of the American Medical Association during June 1999.

"The MORE trial showed that raloxifene reduces the risk of invasive breast cancer by 72% in women who took this drug daily for four years," said Jane Cauley, DrPH, lead author on the study and associate professor of epidemiology at the University of Pittsburgh Graduate School of Public Health (GSPH). "Specifically, raloxifene reduced the risk of estrogen-receptor positive invasive breast cancer by 84%. This finding indicates that raloxifene is very effective at curbing the development of estrogen-fed breast tumors among older women with an average breast cancer risk."

MORE, a multi-center osteoporosis trial, involved 7,705 post-menopausal women, average age of 66.5 years, with a history of osteoporosis. About 12% reported a family history of breast cancer. Participants were randomly assigned to receive 60 mg or 120 mg of raloxifene per day or a placebo. Neither investigator nor participant knew who received placebos and who received raloxifene.

After four years, 22 cases of breast cancer were confirmed among the 5,129 women assigned to either dose of raloxifene, versus 39 cases among the 2,576 women assigned to the placebo. There were no significant differences in outcome between the group taking 60 mg of the drug and those taking 120 mg. Overall, raloxifene was well tolerated by participants.

The hormone estrogen declines as women pass through menopause. Without it, women suffer problems including hot flashes, bone loss, and changes in cholesterol that could predispose them to heart disease. At the same time, however, estrogen is known to fuel the growth of certain breast and endometrial cancers whose cells have estrogen receptors. For these reasons, investigators have been searching for estrogen alternatives, or selective estrogen-receptor modifiers (SERMs), ...