North America's largest-ever breast cancer enrolls 19,000th participant

Leaders of North America's largest-ever breast cancer prevention trial, the Study of Tamoxifen and Raloxifene (STAR), are striving to reach a major milestone this summer: the enrollment of the study's 19,000th — and final — participant.

With that goal in sight, researchers hope that women will know by 2006 which drug — tamoxifen or its cousin raloxifene — prevents cancer better and with fewer side effects. Dana-Farber heads a group of eight New England facilities that together represent the 22nd most active site among the more than 500 in the United States and Canada participating in the study.

"The 18,000th participant signed up last month, and a nationwide effort is under way to complete enrollment by July," says Dana-Farber's Beth Cahoon, who is in charge of STAR recruitment at DFCI and its affiliates. "Reaching the enrollment target this summer means that preliminary results from the study should be available two years from now."

Launched in 1999, the STAR trial is designed to determine whether the osteoporosis drug raloxifene is as effective as tamoxifen in reducing breast cancer rates. The study is open to healthy postmenopausal women who are at increased risk for breast cancer — because of family history or personal medical factors — but who have never been diagnosed with the disease. Judy Garber, MD, MPH, oversees DFCI's participation in the trial as director of the Friends of Dana-Farber Cancer Risk and Prevention Clinic.

Those taking part in the study receive one of the two medications for five years and are monitored with annual mammograms, biannual breast examinations, and regular blood tests. The trial is being conducted by the National Surgical Adjuvant Breast and Bowel Project, a not-for-profit cancer research group funded by the National Cancer Institute.

Women who are interested in learning more about the STAR trial or want to participate in it are invited to contact Dana-Farber's Jennifer Thibodeau at (617) 632-2261.