Breast cancer trial explores prevention options

October 16, 2006
Women who are at high risk for breast cancer may soon fight it with a new weapon. Preliminary results of a large clinical trial that included New Hanover Regional Medical Center’s Zimmer Cancer Center show the drug raloxifene can be as effective in preventing breast cancer as tamoxifen, with fewer serious side effects.

Tamoxifen has been used for more than 30 years to treat patients with breast cancer and was approved for prevention in 1998. It has been the only FDA-approved drug for the reduction of breast cancer risk. It can have some serious side effects, however, including increased risk of blood clots, uterine cancer, cataracts, and menopausal symptoms.

Raloxifene is FDA-approved for the prevention of osteoporosis. It got the attention of cancer researchers when it was discovered that women who took the drug in an osteoporosis clinical trial developed fewer breast cancers than women taking a placebo.

The Study of Tamoxifen and Raloxifene, or STAR, was designed to compare the two drugs. Funded primarily through the National Cancer Institute, it included 19,747 high-risk women at more than 500 centers across the United States, Canada and Puerto Rico. Forty-four women took part in the study at the Zimmer Cancer Center.

In April, researchers announced early findings in which the women in the study who took raloxifene developed 29 percent fewer blood clots and 36 percent fewer uterine cancers. Both drugs reduced the risk of developing breast cancer by about 50 percent.

"Although no drugs are without side effects, tamoxifen and raloxifene are vital options for women who are at increased risk of breast cancer and want to take action," said Leslie Ford, M.D., associate director for clinical research in NCI's Division of Cancer Prevention. "For many women, raloxifene's benefits will outweigh its risks in a way that tamoxifen's benefits do not."

Laurie Graham, RN, Manager of the Cancer Research Program at NHRMC, said the opportunity to participate in the trial gave local residents and physicians a chance to be on the cutting edge of treatment and prevention.

“We are bringing state-of-the-art research to this community so people don’t have to travel,” said Graham. “Even patients who are not on the study still get the benefit of the knowledge gleaned by the physicians who take part. Everybody benefits.”

For more information about the Zimmer Cancer Center and clinical trials, go to