Study of Tamoxifen and Raloxifene (STAR)
The Study of Tamoxifen and Raloxifene, or STAR, is a clinical trial that
began at an estimated 400 sites across the United States and Canada early
in 1999. Participants in STAR include approximately 22,000 postmenopausal
women who are at increased risk for breast cancer. They have received
a drug that could reduce their chances of developing breast cancer.
STAR builds upon the success of the Breast Cancer Prevention Trial (BCPT),
which showed that high-risk women taking the drug tamoxifen for an average
of four years had a 49 percent reduced chance of developing breast cancer.
STAR will determine whether raloxifene (Evista™), a drug similar
to tamoxifen, is also effective in reducing the chance of developing breast
cancer in women who have not had the disease, and whether the drug has
benefits over tamoxifen, such as fewer side effects. Raloxifene was approved
by the FDA (Food and Drug Administration) as an osteoporosis prevention
drug for postmenopausal women.
Women chosen to participate in STAR are age 35 or older, are postmenopausal,
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 have been randomly
assigned to receive either tamoxifen daily or raloxifene daily for five
years. They will receive close follow-up examinations, including mammograms,
physical examinations, and gynecologic examinations, on a regular basis
for at least 7 years.
The National Surgical Adjuvant Breast and Bowel Project (NSABP), which
runs the trial, selected the 193 main institutions to participate in STAR,
including sites in 48 states, six Canadian provinces, the District of
Columbia, and Puerto Rico. These 193 institutions have formed networks
with other local physicians, creating an estimated 400 active centers
participating in the trial.
Click here to view the
Online Resources page of this Web.
|
