Who can participate?

Every clinical trial has a set of inclusion and exclusion criteria which are used to ensure that subjects who enter this study are medically appropriate candidates for this therapy. For the safety of the subjects, as well as to ensure that the results of this study can be useful for making treatment decisions regarding other women with similar diseases, it is important that no exceptions be made to these criteria for admission to the study.

You may be able to participate in ExCel if:

  • you are 35 years of age or older
  • you are postmenopausal (not having monthly periods)
  • you are at increased risk for developing breast cancer. Some of the factors that can increase your risk are:
    • age
    • family history of breast cancer
    • number of breast biopsies
    • age at first menstrual period
    • age at time of first child’s birth

Unfortunately women who fit certain exclusion criteria cannot participate in the study. Some of the key exclusion criteria are:

  • Premenopausal
  • Taking hormone replacement therapy
  • Diagnosed with primary invasive breast cancer

Why should I participate?

As an ExCel participant you will be a partner in medical research. It is only when individuals agree to participate in these research studies that scientists can discover exactly what benefits exist from new treatments. It is possible that by taking these treatments, you may be decreasing your risk of developing breast cancer. Even if you do not directly benefit, you will be contributing to the knowledge base that will help future generations of women worldwide.

What does it mean to participate in a randomized, double-blind study??

If you decide to participate you will be "randomized" into one of the study groups described. Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor your doctor can choose what group you will be in. You will have a one in two chance of being placed in either group.

This study is a double-blind study, which means that neither you nor the doctor will know if you are taking exemestane or placebo. In an emergency, if the treatment needs to be identified it will be.