News Release

End in Sight For First Phase of Major Breast Cancer Prevention Study

Pittsburgh, PA -- The largest North American breast cancer prevention trial ever undertaken, the Study of Tamoxifen and Raloxifene (STAR), nears completion as the 18,000th woman joined the trial. One thousand more women—19, 000 in all—are still needed to complete this important trial. Researchers predict that women will know by 2006 which drug, tamoxifen or raloxifene, prevents breast cancer better and with fewer side effects. Over 500 sites in the United States, Canada and Puerto Rico are participating in STAR.

The 18,000th participant, Maxine Watson of Mesquite, Tex. hopes that joining STAR through the Baylor-Sammons Cancer Center in Dallas, Tex. will reduce her risk of developing breast cancer. “My sister is a breast cancer survivor, so my other sister and I decided to participate in STAR because we wanted to make a contribution to breast cancer research. Regardless if I am the first or the eighteen thousandth woman who joined, I feel it's a privilege and honor to make a contribution to the STAR trial,” said Ms. Watson. Her husband, Troy, has also seen breast cancer affect more than just the women in their family, “I totally support Maxine's participation in STAR and am thankful that we can be a part of this vital research. Our goal is to not only help Maxine, but to ultimately help others.”

STAR is designed to determine whether the osteoporosis prevention and treatment drug raloxifene (Evista®) is as effective as tamoxifen (Nolvadex®) in reducing breast cancer risk. It is the follow-up study to the landmark Breast Cancer Prevention Trial (BCPT), published in 1998, which led to tamoxifen being approved by the U.S. Food and Drug Administration for risk reduction in women at increased risk for developing breast cancer. STAR began recruiting women in July 1999.

“I’m proud of the decision that Maxine and her sister made to join STAR,” says Michael Grant, MD, STAR principal investigator at Baylor-Sammons Cancer Center. “Because of women like them, and the women who preceded them in earlier studies, we now have the ability to provide better treatment options for women with breast cancer and a prevention option as well.”

Once a woman decides to participate, she is randomly assigned to receive either 20-mg tamoxifen or 60-mg raloxifene daily. She also obtains regular follow-up examinations until the results of the trial are known. According to Millie Arnold, RN, the STAR coordinator who will guide Ms. Watson through the study, “The women in STAR know that their health is our first priority because they are at increased risk for getting this disease. As part of the trial, their care is closely monitored.”

STAR includes postmenopausal women who are at increased risk for breast cancer due to a family history of breast cancer and a combination of personal medical factors. These factors are used to estimate a woman’s individual risk for developing the disease in the next five years and in her lifetime.

When asked what she would say to other women at increased risk for developing breast cancer, Ms. Watson said, “It’s not too late to join STAR. Researchers need one thousand more women before July 2004. Participating is easy and it is something we can do now so that our daughters don’t have to.”

STAR is conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP), a not-for-profit cancer research group, and is funded by the National Cancer Institute. For more information about STAR and/or to locate a STAR center in the United States and Puerto Rico, contact the National Cancer Institute’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). In Canada, contact the Canadian Cancer Society’s Cancer Information Service at 1-888-939-3333.

Alternately, visit www.breastcancerprevention.com to calculate your breast cancer risk or to find more information about STAR.