Centers Selected for STAR, Study of Tamoxifen and Raloxifene

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 NSABP’s 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 study participants.

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 Project’s website (www.nsabp.pitt.edu).