The Study of Tamoxifen and Raloxifene, known as STAR, is one of the largest breast cancer prevention trials ever undertaken. STAR is also the first trial to compare a drug proven to reduce the chance of developing breast cancer with another drug that has the potential to reduce breast cancer risk.
All participants receive one drug or the other for five years.
The maker of Tamoxifen, Zeneca Pharmaceuticals, Wilmington, Del., and the maker of Raloxifene, Eli Lilly and Company, Indianapolis, Ind., are providing their drugs for the trial without charge. Participants will receive the drugs free for the duration of the STAR trial. Information about the safety of Raloxifene is limited compared to the data available on Tamoxifen. Raloxifene was approved in December 1997 by the FDA to prevent osteoporosis in menopausal woman and has been in clinical trials for about five years. Tamoxifen has been approved by the FDA for more than 20 years and has been in clinical trials for about 30 years.