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News Archive - Progress Newsletter Fall, 1999 Online
National Breast Cancer Prevention Study Under Way at Cancer Center
The drug tamoxifen, a proven fighter against breast cancer, may be joined by an equally strong partner in preventing the disease. A nationwide study is under way to determine if the drug raloxifene also is effective in preventing breast cancer, the second-leading cause of cancer death in American women.
The U-M Cancer Center is one of more than 400 institutions in North America participating in the Study of Tamoxifen and Ralo-xifene, which will compare the effectiveness of the two drugs in postmenopausal women.
"This is an important trial for many thousands of women and their families around the world," says Sofia Merajver, M.D., Ph.D., U-M's principal investigator and director of the Breast and Ovarian Cancer Risk Evaluation Clinic. "It will likely change the way we will practice prevention of breast cancer in the next five or 10 years, and stands the chance to make a huge difference."
Tamoxifen is a drug that blocks the effects of the hormone estrogen, which is produced by a woman's ovaries and can promote the growth of some cancers. Blocking or lowering the levels of estrogen in a woman is one way of treating breast cancer.
"Breast cancer arises over many years. We know that it is, initially at least, a slow-growing disease. From that standpoint, we are trying to find ways of interfering with that growth; we are beginning to see that, in some cases, breast cancer may be preventable," says Dr. Merajver.
In 1998, a five-year study by the same group showed that tamoxifen produced a 49-percent drop in the incidence of invasive breast cancer in women at a high risk of developing the disease.
Like tamoxifen, raloxifene is an anti-estrogen drug; it was approved by the Food and Drug Administration in 1997 for the prevention of osteoporosis. Women taking raloxifene in osteoporosis studies have seen a reduction in the incidence of breast cancer.
"The STAR trial will try to answer the following question: 'Of two drugs that interfere with the action of estrogen in the breast, which one is better to decrease the risk and incidence of breast cancer?' That's the primary objective of the trial," says Dr. Merajver.
Sponsored by the National Surgical Adjuvant Breast and Bowel Project, the STAR trial will involve 22,000 postmenopausal women randomly assigned to take either tamoxifen or raloxifene daily for five years. Women will receive regular physical exams, mammograms and gynecological exams throughout the trial.
"This is going to be a pivotal trial to compare two anti-estrogens face-to-face with each other in a randomized way," Dr. Merajver says.
Researchers are excited about the prospect of adding a new weapon to the arsenal of drugs for preventing and treating breast cancer. "There are far too many cases of breast cancer, and it's time we employed all the knowledge we have gathered over the last 30 years of molecular biology research to prevent this disease," Dr. Merajver says.
Women interested in participating in the STAR trial will undergo a simple risk assessment to determine if they are eligible.
For more information, call Cancer AnswerLine™ at (800) 865-1125.
This publication is now a part of the Cancer Center's News Archive. It
is listed here for historical purposes only.
U-M Comprehensive Cancer Center