PITTSBURGH--The National Surgical Adjuvant Breast and Bowel Project
(NSABP) has selected 193 institutions to participate in its second
major breast cancer prevention trial--the Study of Tamoxifen and
Raloxifene (STAR)--which is expected to begin in early 1999.
The opening of the STAR trial follows closely on the heels of the
NSABPs first breast cancer prevention trial, which showed a 49%
decrease in the incidence of invasive breast cancer in women at
increased risk for the disease who took tamoxifen (Nolvadex),
compared with placebo.
The new study will examine whether raloxifene (Evista), a selective
estrogen-receptor modulator (SERM) used to treat osteoporosis, is
also effective in preventing invasive breast cancer in women who have
not had the disease, and whether it offers any benefits over those
obtained with tamoxifen.
STAR is a randomized, double-blind study designed to include 22,000
post-menopausal women age 35 or older who are at increased risk of
developing breast cancer. Participants will receive either tamoxifen
at 20 mg/d or raloxifene at 60 mg/d, for 5 years. They will undergo
close follow-up examinations, including a mammogram, physical exam,
and gynecologic exam, on a regular basis for at least 7 years.
"We are extremely pleased at the quality and number of
institutions that submitted a proposal to conduct the trial,"
said Norman Wolmark, MD, chairman of the NSABP. "Once those
chosen identify other institutions that will affiliate with them, we
anticipate having 400 active centers in 48 of the United States, 6
Canadian provinces, Puerto Rico, and the District of Columbia. We
made every effort to select qualified centers in as many geographical
areas as possible so that the study is accessible to a large number
of women seeking a possible breast cancer prevention option."
The STAR centers are located at major medical centers and university
hospitals, community hospitals, health maintenance organizations,
Community Clinical Oncology Programs (CCOPs), and physician practice groups.
The study is supported by the National Cancer Institute, Eli Lilly
and Company, and Zeneca Pharmaceuticals. Lilly will provide
raloxifene and Zeneca will provide tamoxifen at no charge to the
Women who wish to receive information about the trial when it becomes
available can contact the NSABP by mail (NSABP, Box 21, Pittsburgh,
PA 15261); by fax (412-330-4660); or through the Internet at the
Projects website (www.nsabp.pitt.edu).