ICI NOLVADEX PREVENTION STUDY FOR WOMEN AT RISK

Executive Summary

ICI NOLVADEX PREVENTION STUDY FOR WOMEN AT RISK of breast cancer should be considered, National Cancer Institute Director Samuel Broder, MD, suggested at a Jan. 26 meeting of the NCI Cancer Prevention and Control Division's Board of Scientific Counselors. Broder suggested the board "discuss . . . a randomized, placebo-controlled study following tamoxifen . . . in a certain population of women who are at risk of breast cancer." He added that "there are pros and cons" for such a study. A nonsteroidal antiestrogenic hormone product, Nolvadex is indicated for treatment of metastatic breast cancer in postmenopausal women but not for prophylactic use. Last May NCI mailed to 12,000 physicians study results on the positive effects of tamoxifen as an adjuvant therapy in stage one, node negative breast cancer patients. "The ball is in your court," Broder told the board. "I could foresee by way of long speculation that we might be able to identify someone who does not have cancer but who does have some abnormality that we might be able to correct in advance." However, he cautioned that the question of safety regarding such a trial "is extremely important."