Fox Chase Cancer Center Chosen to Participate In Second Breast Cancer Prevention Trial
PHILADELPHIA (September 23, 1998) -- Fox Chase Cancer Center has been chosen to participate in the second national breast cancer prevention trial to be conducted by the National Surgical Adjuvant Breast and Bowel Project and sponsored by the National Cancer Institute. The new study of tamoxifen and raloxifene, called STAR, is expected to begin in 1999.
This trial will compare the drug tamoxifen, already proved effective in prevention, with another drug, raloxifene, that may be as good or better in preventing breast cancer in some women. Both drugs are selective estrogen receptor modulators (SERMs), which act like estrogen in some ways but not in others. SERMs appear to block the effects of estrogen that may promote breast cancer, but these drugs act like estrogen in the bones to help prevent osteoporosis.
STAR will allow researchers to determine whether raloxifene is as effective as tamoxifen for preventing breast cancer in postmenopausal women; whether either drug helps reduce rates of heart disease; and to determine the comparative rates of harmful side effects.
Raloxifene is currently approved by the Food and Drug Administration to prevent bone loss in postmenopausal women. Clinical trials designed to study raloxifene's effect on osteoporosis showed that women taking the drug also had a lower rate of breast cancer than a comparative group of women.
Tamoxifen has been used for the past two decades as follow-up therapy for women who already have breast cancer. Recently tamoxifen has proved to reduce the rate of invasive breast cancer by 49 percent among women at high risk of the disease. Last week's final report on tamoxifen results in the first Breast Cancer Prevention Trial also showed a 50 percent reduction in rates of noninvasive breast cancers such as carcinoma in situ.
The most common side effects of both tamoxifen and raloxifene are hot flashes. Both drugs have also been shown to lower levels of the cholesterol associated with heart disease.
In the first breast cancer prevention trial, scientists found that tamoxifen increased a women's chances of three rare but life-threatening health problems. They include endometrial cancer (cancer of the lining of the uterus), pulmonary embolism (blood clot in the lung), and deep vein thrombosis (blood clots in major veins).
Blood clots are also a possible side effect of raloxifene, but this drug does not increase the risk of endometrial cancer. However, raloxifene is limited to women who have passed menopause because of the risk that the drug might cause birth defects in the event of a pregnancy.
Medical oncologist Dr. Mary B. Daly, director of the Margaret Dyson Family-Risk Assessment Program at Fox Chase, will be the Center's principal investigator for STAR.
"Women at high-risk of breast cancer now have a highly effective drug, tamoxifen, to help prevent the onset of the disease," she pointed out. "Raloxifene could offer a safer and equally effective prevention drug that may also prove to have other life-saving benefits."
Tamoxifen (Nolvadex® by Zeneca Pharmaceuticals, Wilmington, Del.) is currently the most widely prescribed cancer drug in the world. It has been used for almost 25 years to treat patients with advanced breast cancer and since 1985 as an adjuvant or follow-up therapy after radiation and/or surgery for early-stage breast cancer.
Raloxifene (Evista® by Eli Lilly and Company, Indianapolis, Ind.) received FDA approval in the United States in early January 1998 and is also approved in several other countries for osteoporosis prevention. Some 12,800 women worldwide have received raloxifene through completed and ongoing clinical trials.
Clinical trials, or protocols, are treatments using new anti-cancer drugs or innovative approaches to therapy. To permit researchers to see the possible benefits of raloxifene versus tamoxifen, 23,000 women will be divided randomly into two groups.
Half of the women in STAR will receive raloxifene; the other half will receive raloxifene. The trial is a double-blinded study, meaning that neither the doctor nor the patient will know which drug is being administered.
Only postmenopausal women who have a definable increased risk of developing breast cancer are eligible to participate in the study. Risk factors include a strong family history of breast cancer, breast lumps requiring biopsy, early menstruation, no children or childbirth after age 30 and older age. Eligibility and risk based on these and other factors will be determined by computer program.
Breast cancer is the most common type of cancer among women in the United States. This year, 178,700 new cases are expected to be diagnosed and approximately 43,500 women will die from breast cancer.
For more information about the study or how to enroll, call the National Cancer Institute's Cancer Information Service at 1-800-4-CANCER.
Community hospitals belonging to Fox Chase Network are also participating in STAR through their affiliation with Fox Chase Cancer Center.
Fox Chase Cancer Center is one of 34 National Cancer Institute-designated comprehensive cancer centers in the nation. The Center's activities include basic and clinical research, prevention, detection and treatment of cancer and community outreach programs.
Fox Chase Cancer Center, part of Temple University Health System, is one of the leading cancer research and treatment centers in the United States. Founded in 1904 in Philadelphia as one of the nation’s first cancer hospitals, Fox Chase also was among the first institutions to receive the National Cancer Institute’s prestigious comprehensive cancer center designation in 1974. Fox Chase researchers have won the highest awards in their fields, including two Nobel Prizes. Fox Chase physicians are routinely recognized in national rankings, and the Center’s nursing program has achieved Magnet status for excellence three consecutive times. Fox Chase conducts a broad array of nationally competitive basic, translational, and clinical research and oversees programs in cancer prevention, detection, survivorship, and community outreach. For more information, call 1-888-FOX-CHASE (1-888-369-2427).