Dr. Joseph Simone, Interim Vice President of Cancer Programs at the University of Utah, announced today that the Huntsman Cancer Institute will participate in an important breast cancer study which will be officially launched today by the National Cancer Institute. Investigators at the Huntsman Cancer Institute are seeking 200 women to participate in this new trial that will study two drugs shown to hold promise in the prevention of breast cancer.
The Study of Tamoxifen and Raloxifene (STAR) will examine the effectiveness of tamoxifen and raloxifene in preventing breast cancer in high-risk women. Tamoxifen has been used for the past twenty years in the treatment of breast cancer. In 1998 the FDA broadened its application by approving it as a preventive drug. Raloxifene was initially developed to combat osteoporosis, but during its five years on the market it has been associated with a decrease in the incidence of breast cancer.
However, both drugs have been linked to some serious side effects, such as blood clots in large veins and the lungs. Tamoxifen may also increase the chance of endometrial cancer (cancer of the lining of the uterus). The primary purpose of the STAR trial is to compare the long-term benefits and risks of both drugs.
Dr. John Ward, principal investigator for the STAR study at the Huntsman Cancer Institute, outlined the criteria that will be used in determining which women are eligible to participate. According to Dr. Ward, women must be postmenopausal and at least 35 years old. They must also be at increased risk of developing breast cancer due to a family history of the disease or other factors, such as age of onset of menstruation and first childbirth. They cannot have a personal history of breast cancer or have taken either tamoxifen or raloxifene. In addition, women with a history of blood clots, stroke or certain types of heartbeat irregularities will not be eligible to participate. Before a woman will be accepted into the study, she must learn about the potential risks of both tamoxifen and raloxifene, and then give her informed consent.
Dr. Ward strongly encourages any women who believe they may qualify for the study, or would like additional information, to contact the Huntsman Cancer Institute's Cancer Information Service at (801) 581-6365 or (888) 424-2100. The Institute will begin assessing volunteer applications today.
In making the announcement, Dr. Simone said "The Huntsman Cancer Institute is an important participant in this clinical trial. The data we gather will be very useful in determining the future of treating and someday preventing breast cancer."
Additional Resources: Replay of NCI's national press conference: available from May 25, 3:00 p.m. EDT by calling: 1-800-475-6701. The replay access code is 448862.
Internet: Print materials, broadcast quality audio clips, and downloadable photographs available via Internet at time of press conference at:
http://www.nsabp.pitt.edu OR http://cancertrials.nci.nih.gov
Satellite feed for B-roll from NCI: for technical information call Shari Smilowitz at 1-800/920-6397
2:30 p.m EDT, C band, Telstar 5, Transponder 15, Audiolink 6.2/6.8, Downlink frequency 4000
2:45 p.m. EDT, KU band, Telstar 5, Transponder 11, Audiolink 6.2/6.8, Downlink frequency 11929
For specific information regarding tamoxifen or raloxifene: please contact the following public affairs individuals at Zeneca Pharmaceuticals or Eli Lilly and Company:
Mary Lynn Carver Ð Zeneca Pharmaceuticals: 302-886-7859 (eastern time)
Angela Sekston Ð Eli Lilly and Company: 317/276-6337 (central time)