STAR Clinical Trial Controversial Among Some Advocacy Groups

The NCI brushed aside the concerns of some cancer advocacy groups and decided to begin the Study of Tamoxifen and Raloxifene (STAR),expected to be one of the largest breast cancer prevention trials ever. Raloxifene (Evista) was approved by the FDA in December 1997 to prevent osteoporosis. Tamoxifen (Nolvadex) received FDA approval in October 1998 to reduce the risk of breast cancer in women at high risk for the disease. The STAR trial will compare the impact of the two drugs on women at risk for breast cancer, with particular emphasis on side effects. Women in previous trials of both raloxifene and tamoxifen have shown an increased incidence of deep vein thrombosis and pulmonary embolism, but raloxifene has not produced the endometrial cancer risk that tamoxifen has.

In announcing STAR, Donna Shalala, secretary of the Department of Health and Human Services, said, “Women who are at high risk of developing breast cancer need more and better prevention options, and only through clinical trials such as STAR will we find those options.” But groups such as the National Breast Cancer Coalition have strong reservations. The group said in a statement: “What we do know about tamoxifen as risk reduction is known only for the population of women who actually enrolled in the tamoxifen prevention trial. It is inappropriate to study a different population of healthy women as planned for the STAR trial.”