Study Of Tamoxifen And Raloxifene

The STAR trial is a phase III, double blind trial that is assigning eligible postmenopausal women to either 20 milligrams daily tamoxifen or 60 milligrams daily raloxifene therapy for 5 years. Trial participants will complete a minimum of 2 additional years of follow-up after therapy is stopped.

The STAR trial's primary aim is to determine if long-term raloxifene therapy is effective at preventing the occurrence of invasive breast cancer in high-risk postmenopausal women. It will additionally compare cardiovascular data, fracture data, and general toxicities for raloxifene and ta-moxifen. It is clear that the activation or suppression of various target sites is similar for ta-moxifen and raloxifene, but evaluation of the comparative benefits of the agents will provide an important new clinical database for raloxifene in postmenopausal women.

Premenopausal women at risk for breast cancer are currently ineligible for the STAR trial. Although there is extensive information about the efficacy of tamoxifen in premenopausal treatment and prevention of breast cancer,47,106 clinical experience with raloxifene is confined to postmenopausal women. The National Cancer Institute is currently conducting a randomized study of 60 and 300 milligrams daily raloxifene in high-risk women to address its effect on bone density. Additionally, short-term raloxifene treatment up to 28 days causes elevation in circulating estradiol but does not prevent ovula-tion,204 consistent with the known elevation of steroid hormones produced by tamoxifen in premenopausal breast cancer patients.205 The changes in endocrine function produced by raloxifene will also be assessed as a prelude to the recruitment of premenopausal high-risk women to the STAR trial.

The results of the STAR trial are expected by 2006. Clearly, it will be invaluable to establish the overall benefits of the drugs with regard to breast cancer incidence, coronary heart disease, and osteoporosis. Comparisons of endometrial cancer will be especially interesting because the standard of care, i.e., self-reporting, will be employed in the STAR trial rather than routine screening with annual biopsies.

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