FOR IMMEDIATE RELEASE
Contacts:
Michael Courtney, (713) 792-0655
[email protected]
Alison Ruffin, (713) 792-3363
M. D. Anderson begins participation in multi-nation study of two breast cancer prevention drugs
HOUSTON--The University of Texas M. D. Anderson Cancer Center is recruiting women for one of the largest breast cancer prevention studies conducted to date.
M. D. Anderson is among more than 400 centers across the United States, Canada and Puerto Rico participating in the Study of Tamoxifen and Raloxifene -- known as the STAR trial. Organizers of the medical study, part of the National Surgical Adjuvant Breast and Bowel Project supported by the National Cancer Institute, plan to enroll 22,000 women in the STAR trial, all postmenopausal women at increased risk for breast cancer. M. D. Anderson plans on enrolling 400 participants in the STAR project.
We are excited about bringing the STAR trial to the greater Houston metropolitan area," said Dr. Therese B. Bevers, principal investigator at M. D. Anderson in an announcement made today (Tuesday, May 25). "Women everywhere are at risk for breast cancer, and we are pleased that Houston-area women will have the chance to participate in this important study."
Until a year ago, when the results of the five-year tamoxifen study were announced, women with an increased risk of breast cancer had no proven way to reduce their chance of getting the disease. The new study will compare tamoxifen, which was found to reduce breast cancer risk by half, to a newer drug called raloxifene. The STAR research will determine which drug might be more effective and have fewer side effects for women past menopause who are at high risk of breast cancer.
The medical study on tamoxifen called the Breast Cancer Prevention Trial, enrolled more than 13,000 premenopausal and postmenopausal women at high risk of breast cancer. Results of the trial were published in the Journal of the National Cancer Institute's Sept. 16, 1998, issue. The tamoxifen study was a double-blind study in which neither study participants nor physicians knew who was taking tamoxifen and who was taking the placebo (an inactive pill that looked like tamoxifen). In addition to reducing their breast cancer risk by half, participants taking tamoxifen also had fewer fractures of the hip, wrist and spine than did women taking the placebo.
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 large veins), pulmonary embolism (blood clot in the lung), and possibly stroke. The U. S. 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.
"Tamoxifen is a medically proven intervention, but is not perfect," said Dr. Bevers. "Women who are at an increased risk of breast cancer need options for preventing this disease with a minimum of side effects, and STAR is a concerted effort to find one."
Information about the safety of raloxifene is limited compared to the data available on tamoxifen, she noted. Raloxifene was approved in December 1997 by the FDA to prevent osteoporosis and has been in clinical trials for about five years. Tamoxifen has been approved by the FDA for more than 20 years to treat women with breast cancer, and it has been in clinical trials for about 30 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. In these studies, raloxifene did not increase the risk of endometrial cancer. 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 having first child. They also will 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 milligrams of tamoxifen or 60 milligrams of raloxifene daily for five years and will have regular follow-up examinations, including mammograms and gynecologic exams.
The maker of tamoxifen, Zeneca Pharmaceuticals of Wilmington, Del., and the maker of raloxifene, Eli Lilly and Company of Indianapolis, Indiana, are providing their drugs for the trial without charge. More information about STAR may be found on the Internet at M. D. Anderson's website: http://www.mdanderson.org. Also, more information may be obtained at the National Surgical Adjuvant Breast and Bowel Project website: http://www.nsabp.pitt.edu, or at the National Cancer Institute's clinical trials website at http://cancertrials.nci.nih.gov.
Satellite study sites include St. Luke's Episcopal Hospital in Houston, the Memorial Health System of East Texas/Arthur Temple Sr. Regional Cancer Center in Lufkin, the Providence Memorial Hospital in El Paso and the M. D. Anderson Cancer Center in Orlando, Fla.
For more information, call the "STAR line" at M. D. Anderson at (713) 792-8064. Additional information about the medical study also may be obtained from the Cancer Information Service at 1-800-4--CANCER.
Persons diagnosed with cancer who are interested in clinical trials of new therapies may call The
M. D. Anderson Information Line at 1-800-392-1611 (Touch 3).
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5/25/99
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