Four Rochester Area Hospitals Participate In Major Breast Cancer Prevention Trial
May 26, 1999
In a collaborative venture, Strong Memorial Hospital, Highland Hospital and ViaHealth's Genesee Hospital and Rochester General Hospital are recruiting volunteers to participate in the national Study of Tamoxifen And Raloxifene (STAR) - one of the largest breast cancer prevention studies ever conducted. Altogether, 400 centers across the United States, Canada and Puerto Rico will be involved in the study.
The trial anticipates enrolling 22,000 postmenopausal women at increased risk of breast cancer to determine whether the osteoporosis prevention drug raloxifene (Evista®) is as effective in reducing the chance of developing breast cancer as tamoxifen (Nolvadex®) has proven to be.
"Breast cancer continues to be a major health threat for women, so we are excited about investigating the merits of another drug that we may be able to use in our battle against breast cancer," says Gary R. Morrow, Ph.D., associate director for Community Research at the University of Rochester Cancer Center and principle investigator of the STAR trial for Rochester. "Studies of raloxifene suggest it has the potential to prevent breast cancer. The only way to prove that potential is to do a clinical trial in which the risks and benefits of raloxifene are directly compared with the risks and benefits of tamoxifen."
The four hospitals have set up a single telephone number, 275-STAR, which women can call to learn more about the study or to volunteer for it.
Tamoxifen was shown to reduce the chance of developing breast cancer by about half in the Breast Cancer Prevention Trial (BCPT), a study of over 13,000 premenopausal and postmenopausal women at high risk of breast cancer, results of which were announced a year ago.
In the BCPT, half the women took tamoxifen and half took a placebo. Participants taking tamoxifen also had fewer fractures of the hip, wrist and spine than women taking the placebo did.
However, the drug increased the women's chances of developing four potentially life-threatening health problems: endometrial cancer (cancer of the lining of the uterus), deep vein thrombosis (blood clots in the large veins), pulmonary embolism (blood clot in the lung), and stroke. The US Food and Drug Administration (FDA) approved the use of tamoxifen to reduce the incidence of breast cancer in women at increased risk of the disease in October 1998.
Information about raloxifene's safety is limited compared to the data available on tamoxifen. The FDA approved the use of raloxifene in December 1997 to prevent osteoporosis; it has been in clinical trials for about five years. Women taking raloxifene in studies of osteoporosis have had an increased chance of developing a deep vein thrombosis or pulmonary embolism similar to the risk seen with tamoxifen, but it did not increase the risk of endometrial cancer.
Tamoxifen has been approved by the FDA to treat women with breast cancer for more than 20 years and has been in clinical trials for about 30 years. An important part of STAR will be to compare the long-term safety of raloxifene and tamoxifen in women at increased risk for breast cancer.
Women who participate in STAR must be postmenopausal, at least age 35, and have an increased risk of breast cancer as determined by their age, family history of breast cancer, personal medical history, age at first menstrual period, and age at first live birth. They will also go through a process known as informed consent, during which they will learn about the potential benefits and risks of tamoxifen and raloxifene before deciding whether to participate in STAR.
Once a woman chooses to participate, she will be randomly assigned to receive either 20 mg of tamoxifen or 60 mg of raloxifene daily for five years, and will have regular follow-up exams, including mammograms and gynecologic exams.
The maker of tamoxifen, Zeneca Pharmaceuticals, and the maker of raloxifene, Eli Lilly and Company, are providing their drugs for the trial without charge. Eli Lilly and Company has also given NSABP a $36 million grant to defray recruitment costs at the participating centers and to help local investigators conduct the study.
The STAR trial is supported by the National Cancer Institute (NCI) and will be conducted in Rochester by members of the Rochester Cancer Prevention Network, who, in addition to Drs. Morrow and Caldwell, are Darlene Gibbon, M.D., Jennifer J. Griggs, M.D., Jane Hickok, M.D., Zachary B. Kramer, M.D., Beth A. Martin, M.D., Kishan J. Pandya, M.D., Raman Qazi, M.D., Julia L. Smith, M.D., and Wende W. Young, M.D.