STAR Trial (Study of Tamoxifen and Raloxifene)

This study is active, but we are no longer enrolling candidates.

The National Surgical Adjuvant Breast and Bowel's Project (NSABP) membership committee selected the University of Chicago as one of 193 institutions to participate in its second major breast cancer prevention trial.

The Study of Tamoxifen and Raloxifene (STAR) began in May, 1999. The opening of the STAR trial followed closely on the heels of the NSABP's first breast cancer prevention trial. In that study, researchers found a 49% decrease in the incidence of invasive breast cancer in women at increased risk for the disease who took tamoxifen therapy, in comparision to those who took an inactive placebo (sugar pill).

This current study is examing whether raloxifene, a drug similar to tamoxofen, 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 23,000 post menopausal women 35 or older who are at increased risk for developing breast cancer.

Volunteers who enrolled were randomly assigned to a regimen of 20mg of tamoxofen or 60 mg of raloxifene daily for five years. They are receiving close follow-up examinations, including mammograms, physical exams, and gynecological exams on a regular basis for at least seven years.