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New Breast Cancer Study
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| As northeastern New York’s principal research base for The Study of Tamoxifen and Raloxifene, The Cancer Center at Glens Falls Hospital will oversee the participation of hospitals from north of Poughkeepsie to the Canadian border, including Albany Medical Center Hospital and Albany Regional Cancer Center. |
Maggie Usher of South Glens Falls lost her mother and sister to breast cancer. She’s hoping a major national breast cancer prevention trial now underway through The Cancer Center at Glens Falls Hospital will help her avoid the disease.
The trial is known as STAR — the Study of Tamoxifen and Raloxifene — and The Cancer Center has been designated as northeastern New York’s principal research base. STAR is designed to determine if the osteoporosis prevention drug raloxifene as effective in reducing the risk of developing breast cancer as the drug tamoxifen has been shown to be.
"This is a project that is very important to me," says Maggie, a retired registered nurse. "I hope to participate and play a role in someday finding a cure."
STAR is being conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), with support from the National Cancer Institute, and is open to postmenopausal women age 35 and older who are at increased risk for developing the disease. More than 20,000 women are expected to take part in the trial nationwide. Cancer Center officials hope to recruit 200-500 area women.
"This is one of the most important public health trials taking place in this country today," says Robert W. Sponzo, M.D., director of The Cancer Center and the region’s principal investigator for the trial. "STAR provides local women and our staff with an unprecedented opportunity to make a difference in the lives of women, not just today, but for generations to come."
Tamoxifen has been approved by the U.S. Food and Drug Administration for use in reducing the incidence of breast cancer in women at increased risk of the disease. This approval followed an announcement by NSABP last year that a groundbreaking, five-year trial found a 49% decrease in the incidence of invasive breast cancer in women who took tamoxifen in comparison to those who took a placebo. The Cancer Center was a research base for that trial as well.
Raloxifene was approved by the FDA for the prevention of osteoporosis in postmenopausal women in 1997, following five years of clinical trials. During these studies, it was also discovered that women taking the drug developed fewer breast cancers than women taking a placebo. STAR will compare the effectiveness and side effects of the two drugs.
Women who participate in the trial must be postmenopausal, age 35 or older, and have an increased risk of developing 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.
Participants will be randomly assigned to receive either a daily dose of tamoxifen or raloxifene for five years. Neither the woman nor her doctor will know which drug the participant is receiving. Participants will also have regular follow-up examinations, including mammograms and gynecologic exams.