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In this study, there is a 1 in 2 chance that you will receive only placebo (an inactive substance). You may have concerns about taking part in the study because of this. However, this is the best way we have to see if a new therapy is effective, and to clearly see the potential side effects and impact on quality of life. Three other breast cancer prevention studies have already been done. These studies all compared tamoxifen to placebo. All 3 of these studies have shown that certain groups of women who took tamoxifen greatly lowered their chance of getting breast cancer. These groups were women 35-59 years old who had an above average risk of developing breast cancer and women older than 60 years who had an average or high risk of developing breast cancer. Because of its side effects, tamoxifen has only been approved by the U.S. Food and Drug Administration (FDA) for preventing breast cancer in women who are at "high risk". For example, tamoxifen caused endometrial cancer, stroke, blood clots and eye problems (cataracts) especially in older women who were past menopause. It also caused increased symptoms in women in menopause such as hot flashes, vaginal discharge and genital itch. The benefit of tamoxifen is best seen in young women before menopause. It is less helpful to women who have past menopause. The American Society of Clinical Oncology has noted the side effects of tamoxifen. They also noted that the tamoxifen clinical trials have not clearly shown this drug has a good effect on overall health and helps to lower the rate of death from breast cancer. The Society has therefore recommended the use of a placebo in breast cancer prevention clinical trials to help ensure studies provide clear information about the potential benefits of treatments being tested. |
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