The largest North American breast cancer prevention trial ever undertaken, the Study of Tamoxifen and Raloxifene (STAR), reached its goal of enrolling 19,000 women to the trial in June 2004―a month earlier than originally expected. Women still being evaluated for the study will be allowed to join the trial until October 2004. Researchers from the National Surgical Adjuvant Breast and Bowel Project (NSABP) predict that women will know which drug, tamoxifen (Nolvadex®) or raloxifene (Evista®), is more effective in preventing breast cancer with fewer side effects by the summer of 2006. Over 500 sites in the United States, Canada, and Puerto Rico, including Decatur Memorial Hospital, are involved in STAR.
"It’s a remarkable achievement," said James L. Wade, M.D., Principal Investigator of the Central Illinois Community Clinical Oncology Program. "Women at increased risk for developing breast cancer chose to be proactive about finding options to prevent the disease. We owe a debt of gratitude to these women who are leading the charge in preventing breast cancer."
Those participating in STAR are randomly assigned to tamoxifen or raloxifene for five years. Women enrolled in STAR will continue to obtain close follow-up care until study results are known. STAR began in 1999 and some women have already completed their five years of study treatment.
Tamoxifen, a mainstay in breast cancer treatment, is also approved for breast cancer risk reduction in women with an increased risk of getting the disease. Raloxifene is approved to prevent and treat osteoporosis in postmenopausal women. The initial results of the STAR trial should be available by early 2006.
"The deepest gratitude comes from those who have and will benefit from this next tier of accepted treatment regimens," stated Liz Swords, Decatur Memorial Hospital Director of Clinical Research. "Data from these large-scale clinical trials in breast cancer prevention is critically important and will provide women at increased risk for breast cancer the opportunity to make the wisest choices about their health. The women who have chosen to join this trial are advancing the medical frontier and deserve to be congratulated."
STAR is conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), a not-for-profit cancer research group, and is funded primarily by the National Cancer Institute. Eli Lilly, Indianapolis, Ind. has provided the raloxifene and AstraZeneca Pharmaceuticals, Wilmington, Del. has provided the tamoxifen for the trial at no charge.
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ENROLLMENT ENDS AHEAD OF SCHEDULE FOR MAJOR
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