Press Release

May 8, 2006
Contact: Tom Capezzuto
Phone: (973) 972-3000
capezzta@umdnj.edu

Participants Sought for Study by UMDNJ Researcher to Test Effects of
Oral Drug to Prevent Onset of Breast Cancer in Healthy Women at Risk

NEWARK—Postmenopausal women at increased risk of contracting breast cancer based on family history are being sought for a landmark study at the University of Medicine and Dentistry of New Jersey to assess a new preventive medication.

The clinical trial involves the drug, Exemestane, an aromatase inhibitor that is being used to treat breast cancer victims around the world.

The research, called the ExCel study, will evaluate the drug’s ability to prevent the disease in healthy women, said Dr. Norman L. Lasser, a professor of medicine at the UMDNJ-New Jersey Medical School and director of the Women’s Health Initiative, a 17-year study of women’s health issues that was funded by the National Institutes of Health.

The clinical trial, he noted, began last year but the medical school is looking for new participants for the study to better gauge Exemestane’s ability to prevent the development of breast cancer in healthy postmenopausal women.

"We will be evaluating the effects of Exemestane on women who are at least 35 years of age, postmenopausal, and at an increased risk of developing breast cancer based on age, family history, age at first menstrual period and age at time of first child’s birth," Dr. Lasser said.

In a previous national study, this drug demonstrated an ability to prevent the occurrence of new cancers in the opposite breast of women being treated with Exemestane, suggesting that it may prevent the disease in healthy women, too. The drug is manufactured by Pfizer, Inc.

The drug previously was approved by the U.S. Food and Drug Administration in 1999 for treatment of advanced breast cancer in postmenopausal women whose tumors had stopped responding to tamoxifen therapy. A study published by the New England Journal of Medicine last year revealed that 32 percent fewer women had a recurrence of breast cancer when they switched to Exemestane after two or three years of tamoxifen, compared to those who continued on tamoxifen for a total of five years.

"The study also found that twice as many women receiving tamoxifen developed second or new breast cancers than those treated with Exemestane," Dr. Lasser said.

Unlike other aromatase inhibitors, Exemestane is a steroidal aromatase inactivator, meaning it selectively targets and irreversibly binds to the aromatase enzyme, which is required to produce estrogen, Dr. Lasser explained. Without estrogen, breast cancer cells cannot survive.

Postmenopausal women interested in participating in the ExCel study may call Dr. Lasser's office for consultation and screening at (973) 972-6107.