SEATTLE -- The Fred Hutchinson Cancer Research Center's Puget Sound Oncology Consortium (PSOC) is a local coordinating and recruitment site for the national Study of Tamoxifen and Raloxifene, or STAR, one of the largest breast cancer prevention studies ever.
The five PSOC satellite sites are Olympic Hematology and Oncology in Bremerton, Rockwood Clinic in Spokane, St. Charles Medical Center in Bend, Ore., St. Joseph Hospital Community Cancer Center in Bellingham and Swedish Medical Center in Seattle. The PSOC physicians and satellites will recruit 300 women from the Pacific Northwest region.
"We are excited to be part of such an important study," said Rick Clarfeld, M.D., principal investigator for STAR. "Women everywhere are at risk for breast cancer, and we hope local women are interested in being part of a study that we will provide more information about the prevention of breast cancer."
The trial involves 400 centers across the United States, Canada, and Puerto Rico. The goal is to recruit 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.
As part of the National Surgical Adjuvant Breast and Bowel Project (NSABP), the network of research professionals that will conduct STAR, which is supported by the National Cancer Institute (NCI). NSABP chairman Norman Wolmark, M.D., noted that "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."
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 tamoxifen or 60 mg raloxifene daily for five years and will have regular follow-up examinations, including mammograms and gynecologic exams.
How to participate
Fred Hutchinson Cancer Research Center's Puget Sound Oncology Consortium
Rick Clarfeld, M.D., principal investigator for STAR
Joelle Machia, R.N., coordinator for STAR
For information or enrollment, call (206) 667-6544
Women interested in participating in the project may call:
Seattle: The Fred Hutchinson Center, 206-667-6544; Swedish Medical Center, 206-386-6132; Virginia Mason Medical Center, 206-223-6946.
Bremerton: Olympic Hematology and Oncology, 360-479-6154.
Spokane: Rockwood Clinic, 509-838-2531, Ext. 3267.
Bellingham: St. Joseph Hospital Community Health Center, 360-734-5400, Ext. 2611.
Tacoma: Multicare Health Center, 253-552-1461.
Bend, Ore.: St. Charles Medical Center, 541-317-4359.
The maker of tamoxifen, Zeneca Pharmaceuticals, Wilmington, Del., and the maker of raloxifene, Eli Lilly and Company, Indianapolis, Ind., 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.
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 this trial were announced a year ago (April 6, 1998) and published in the
Journal of the National Cancer Institute on Sept. 16, 1998. In the BCPT, half the women took tamoxifen and half took a placebo (an inactive pill that looked like tamoxifen). Participants taking tamoxifen also had fewer fractures of the hip, wrist, and spine than women taking taking 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.
Leslie Ford, M.D., associate director for clinical research in NCI's Division of Cancer Prevention, noted that "tamoxifen is a medically proven intervention, but it is not perfect. 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." Ford is responsible for all aspects of NCI's involvement in STAR.
Information about the safety of raloxifene is limited compared to the data available on tamoxifen. 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 to treat women with breast cancer for more than 20 years and 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.
The Fred Hutchinson Cancer Research Center is an independent, non-profit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone marrow transplantation, the Center has four scientific divisions collaborating to form a unique environment for conducting basic and applied science. One of 35 National Cancer Institute-designated comprehensive cancer centers in the country, it is the only one in the Northwest. For more information, visit the Center's web site at http://www.fhcrc.org.
For more information about STAR contact the PSOC Coordinating Site at (206) 667- 6544 or visit NSABP's Web site at http://www.nsabp.pitt.edu or NCI's clinical trials Web site at http://cancertrials.nci.nih.gov.
Note to editors: There are two additional sites in the Seattle-Tacoma area that are recruiting women for STAR. To provide the all options for women please include these in your news pieces. Virginia Mason Medical Center at (206) 223-6946 and NW CCOP at Multicare Health Center in Tacoma at (253) 552-1461.
EMBARGOED FOR RELEASE
Tuesday, May 25, 1999, 10 a.m. EDT
Contact: Susan Edmonds (206) 667-2896