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March 29, 2005
Communications Consultant, LRCP
Postmenopausal Women at Increased Risk for Breast Cancer Can Participate in Clinical Trial
London, Ontario, Canada. March 29, 2005: London Regional Cancer Program (LRCP), London Health Sciences Centre 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 (NCIC CTG), the ExCel research study will follow more than 4,500 women from Canada, the United States and Spain, over a five-year period.
"We are excited to be one of the institutions selected to participate in this landmark study because, through exemestane, we may have a new option for preventing this disease," said Dr. Eric Winquist, Medical Oncologist, LRCP. "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."
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 being used to treat breast cancer recurrence 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.
"Research already suggests that diet and exercise may be effective ways women can reduce their risk of breast cancer - a disease we know takes a tremendous toll on Canadian women and their families. We're looking forward to the results of this research and the possibility of providing women with another option for breast cancer prevention," says Dr. Barbara Whylie, CEO of the Canadian Cancer Society. The NCIC CTG is supported by funds raised by the Canadian Cancer Society.
Women looking for more information about the ExCel research study should call:
1-519-685-8414 or 1-866-212-2084, or visit www.excelstudy.com
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, Ontario, in cooperation with physicians in Canada, the United States and Spain. Pfizer manufactures exemestane 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.
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.