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Will I need to see my regular doctor? How is the safety of participants ensured? Is the trial monitored? What are the common side effects of exemestane? Why can't premenopausal women participate in ExCel? Why is this study being done? In 1998, tamoxifen was identified as the first drug treatment available to women for the prevention of breast cancer. However, tamoxifen can cause a number of serious side effects in women including cancer of the uterus and blood clots. Therefore, women need to seriously consider both the risks and benefits of tamoxifen use before accepting it. Scientific evidence suggests that the treatment being tested in the ExCel research study (exemestane) may also help prevent breast cancer, and with fewer side effects. However, the only way to find out for sure is to test them on healthy women who, for a number of reasons, may have a greater than average risk of developing breast cancer. If successful, we may have another option for breast cancer prevention that has fewer serious side effects than tamoxifen. Will I need to see my regular doctor? Participating in a clinical study does not replace your regular medical care. You should continue to see your regular doctor. If you are accepted into the study, it will be important for your doctor to know about your participation. How is the safety of participants ensured? Is the trial monitored? Participant safety is central to the clinical trial process and very important to ExCel investigators. The clinical trial process involves many safeguards to ensure that a participant’s well-being is protected at all times. There are strict requirements about who can join the trial. The health care team in each centre will closely monitor participants’ health and watch for any side effects. There is an independent Data Safety and Monitoring Committee (DSMC) that will provide oversight of the trial. The DSMC includes medical and cancer specialists, biostatisticians and lay people. The DSMC will meet every 6 months to review the safety data from all participants. In addition, the DSMC is available to review the trial safety data, any time, at the request of the NCIC CTG trial team. All centres will also be audited by the NCIC CTG to ensure they are following the protocol and working within the Good Clinical Practice guidelines. Click here to access the Good Clinical Practice guidelines. What is exemestane used for? High levels of estrogen - especially in postmenopausal women - can increase the risk of breast cancer, because estrogen plays a key role in the development and growth of some types of breast cancer. Even when the ovaries stop making estrogen after menopause, the body still continues to produce it in low levels. Exemestane stops the production of estrogen and its supply to pre-cancerous and cancerous cells, therefore, preventing them from growing. Exemestane is a treatment being used successfully in women with breast cancer and it has been shown to be highly effective in preventing the disease from returning. It also prevents the occurrence of new cancer in the opposite breast, suggesting that it may prevent the disease in healthy women. Exemestane is approved by the Food and Drug Administration in the U.S. and Health Canada and is marketed as Aromasin™. What are the common side effects of exemestane? Exemestane is well-tolerated and side effects associated with this treatment are generally predictable and manageable. However, as with most medications including over the counter preparations, prescription drugs and drugs used in research studies, exemestane may cause side effects in some women. The known symptoms for exemestane are related to the suppression of estrogen and may include hot flashes; low grade nausea is seen occasionally. Few women stop taking exemestane for side effects. Please speak to the Excel investigators for more information on possible side effects. Why can't premenopausal women participate in ExCel? Exemestane is one member of a class of drugs called aromatase inhibitors. Exemestane, given alone, is not recommended in premenopausal women for 2 reasons:
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