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International breast cancer prevention study to start soon in United States and Canada

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International breast cancer prevention study to start soon in United States and Canada
International breast cancer prevention study to start soon in United States and Canada
  March 31, 2005. A new prevention clinical trial to evaluate the efficiency of a novel approach for prevention of breast cancer is to be launched in the United States and Canada soon. This trial, which is called the ExCel research study, is the first North American clinical trial to evaluate the role of an aromatase inhibitor for the prevention of breast cancer. The study is conducted by National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), the ExCel research study. This study will examine the potential benefit of exemestane (Aromasin) and its ability to prevent breast cancer in women who are at higher risk for the disease. Exemestane (Aromsin) is part of a class of drugs called aromatase inhibitors which suppresses estrogen production, a key component in the development of hormone receptor positive breast cancer. Exemestane (Aromsin) could provide women with an alternative option to tamoxifen, the only drug FDA approved for prevention of breast cancer.

The ExCel research study is planning to enroll more than 4,500 postmenopausal women from the U.S., Canada and Spain over a five year period. To be eligible, women must be 35 years of age or older and have an increased risk of developing breast cancer. These increased risk factors could include a woman's age, her family history of breast cancer, her age at first menstrual period and her age at first live birth.
Initial results of the trial could be available within four years and study investigators expecting to see as much as a two-thirds reduction in the incidence of breast cancer among women in the treatment group.

Many Aromatase inhibitors are in use currently for the treatment of breast cancer. Some of them like Arimidex and exemestane are used post-operatively after the diagnosis of breast cancer, other like Letrozole are mainly used for the treatment of hormone receptor positive metastatic breast cancer. Clinical studies have also shown that aromatase inhibitors are associated with fewer serious side effects than tamoxifen, the only other drug available to women for primary breast cancer prevention. 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.

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. Women will 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.

Women will have a screening visit with a member of the study's clinical staff to see if they are eligible for the trial. If eligible, they will undergo a routine health examination, routine blood tests, a mammogram and a bone mineral density test.

The National Cancer Institute of Canada Clinical Trials Group (NCIC CTG), based at Queen's University in Kingston Ontario, is working in cooperation with physicians in Canada, the U.S. and Spain to coordinate the ExCel research study. Pfizer, Inc. manufactures exemestane under the brand name Aromasin and is providing the drug for the trial.

Women looking for more information about the ExCel research study and participating study centers in their community can visit or call toll-free:
  • In the U.S. 1-800-4-CANCER
  • In Canada 1 888 939-3333

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