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DRAFT Contact:
Jennifer Day
Wayne State School of Medicine
P. 313-577-1058
jday@med.wayne.edu

WSU School of Medicine enrolls women in landmark breast cancer prevention study

Postmenopausal women at increased risk for breast cancer eligible to participate

The Wayne State University School of Medicine is enrolling postmenopausal women at increased risk for breast cancer in a new clinical trial evaluating the role of an aromatase inhibitor in the prevention of the disease. Coordinated by the National Cancer Institute of Canada Clinical Trials Group with the support of Pfizer Inc. and in cooperation with women’s health and cancer centers in the United States, Canada and Spain, the ExCel research study will follow more than 4,500 women over a five-year period.

“We hope that women from across our community will consider participating in the trial as the results may have a direct impact on the future of breast cancer prevention,” said Susan Hendrix, D.O., WSU professor of obstetrics & gynecology.

The ExCel research study will examine the potential benefit of exemestane in postmenopausal women, 35 years of age or older, who have an increased risk of developing breast cancer. Risk factors include, but are not limited to, age, family history, age at first menstrual period and age at time of first child’s birth.

Exemestane is a member of a class of drugs called aromatase inhibitors currently used to treat breast cancer in women around the world. Results from a study published in a March 2004 issue of the New England Journal of Medicine demonstrated that exemestane was able to prevent the occurrence of new cancers in the opposite breast of women who have already had breast cancer, suggesting that it may prevent the disease in healthy women.

Women looking for more information about the ExCel research study should contact (313) 745-7156 or visitwww.excelstudy.com.

With more than 1,000 medical students, the WSU School of Medicine is among the nation’s largest institutions of its kind. Together with its clinical partner, the Wayne State University Physician Group, the school is a leader in patient care and medical research with emphases on cancer, maternal and child health, neurosciences, and population studies and urban health .

About the ExCel Research Study

To participate in the study, women will have a screening visit with a member of the study’s clinical staff to see if they are eligible for the trial. Breast cancer risk will be determined by factors that include age, family history, age at first menstrual period and age at time of first child’s birth. If eligible, women will undergo a routine health examination, routine blood tests, a mammogram and a bone mineral density test.

Women enrolled in the ExCel research study will be randomized to one of two groups and all will take one pill per day for five years. Group A will take exemestane and Group B will take a placebo. Participants will be expected to participate in two follow-up visits during the first year – at six and 12 months – and then an annual follow-up visit during years two through five.

The ExCel research study is coordinated by the NCIC CTG, based at Queen’s University in Kingston, Ont., in cooperation with physicians in the United States, Canada and Spain. Pfizer manufactures exemestane, under the brand name Aromasin ®, and is also providing support for the study and the drug for the trial.

Founded in 1971 and funded by the Canadian Cancer Society, the NCIC CTG develops, conducts and analyzes national and international trials of cancer therapy, including trials for new cancer drugs, cancer prevention and supportive care to improve quality of life for people with cancer. Since its inception, the NCIC CTG has enrolled more than 40,000 patients from Canada and around the world in over 300 clinical trials.

About Exemestane

Exemestane was approved by the U.S. Food and Drug Administration in 1999 and by Health Canada in 2000 for the treatment of advanced breast cancer in postmenopausal women whose tumors have stopped responding to tamoxifen therapy. Exemestane is marketed by Pfizer, Inc. as Aromasin ® . It is also approved for use in Europe, Japan, and South America.

Results of the Intergroup Exemestane Study, published in the New England Journal of Medicine, revealed that 32 percent fewer women had a recurrence in their breast cancer when they switched to exemestane after two to three years of tamoxifen compared to those who continued on tamoxifen for a total of five years, the current standard of care. Additionally, twice as many women receiving tamoxifen developed second (or new) breast cancers than those treated with exemestane.

Unlike other aromatase inhibitors, exemestane is a steroidal aromatase inactivator, which means it selectively targets and irreversibly binds to the aromatase enzyme, which is required to produce estrogen. Without estrogen, breast cancer cells cannot survive. Exemestane is well tolerated and the side effects associated with the treatment are generally predictable and manageable. Given its potent suppression of estrogen, exemestane has been associated with low instances of mild nausea and hot flashes.

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