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news.Initial study results have shown that Eli Lilly's osteoporosis drug Evista works as well as tamoxifen in reducing breast cancer risk for postmenopausal women at increased risk of the disease.
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In the study, named STAR, both Evista (raloxifene) and tamoxifen reduced the risk of developing invasive breast cancer by about 50%. In addition, within the study, women who were prospectively and randomly assigned to take raloxifene daily, and who were followed for an average of about four years, had 36% fewer uterine cancers and 29% fewer blood clots than the women who were assigned to take tamoxifen.
Uterine cancers, especially endometrial cancers, are a rare but serious side effect of tamoxifen. Both tamoxifen and raloxifene are known to increase a woman’s risk of blood clots.
Additionally, the initial results suggest that raloxifene does not increase the risk of developing a cataract, as tamoxifen does.
STAR, one of the largest breast cancer prevention clinical trials ever conducted, enrolled 19,747 postmenopausal women who were at increased risk of the disease. Participants were randomly assigned to receive either 60mg of raloxifene, which is currently used to prevent and treat osteoporosis in postmenopausal women, or 20mg of tamoxifen (AstraZeneca’s Nolvadex) daily for five years.
“This optimistic news from STAR is a significant step in breast cancer prevention,” said Dr John Niederhuber, currently providing leadership at the US National Cancer Institute (NCI). “These results, once again, demonstrate the critical importance of clinical trials in our efforts to establish evidence-based practices.”
“Although no drugs are without side effects, tamoxifen and raloxifene are vital options for women who are at increased risk of breast cancer and want to take action,” said Dr Leslie Ford, associate director for clinical research in the NCI’s division of cancer prevention. “For many women, raloxifene’s benefits will outweigh its risks in a way that tamoxifen’s benefits do not.”
The STAR data, coupled with data from other raloxifene trials, will be used by Lilly in a submission to the FDA in support of an indication for Evista for the reduction of invasive breast cancer risk in postmenopausal women.