IRB Number:

675-04

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This research study is being done to test whether exemestane, an investigational drug, will decrease the number of people diagnosed with invasive breast cancer in women at high risk for developing breast cancer. Exemestane is an "investigational drug". The word "investigational" means that the drug has not been approved by the Food and Drug Administration (FDA) for this use in the United States or Canada.

Who is Eligible to Participate in the Study?

• Women at high risk for getting breast cancer.


• No current use of tamoxifen.


• No prior use of tamoxifen to treat breast cancer.

*More specific, detailed eligibility and/or exclusion criteria are associated with this trial.

What is Involved With this Study?

• Patients determined to be at high risk for developing breast cancer will be given information on taking tamoxifen versus participating in this study. Patients choosing to start tamoxifen, will not be eligible to participate in this study.


• Patients will be randomized to receive either exemestane or placebo.


• Patients will take a pill once a day in the morning.


• Physical exams


• Blood tests


• Mammogram (if not done in past year)


• Bone Density test


• Complete questionnaires

How long will the Study run?

Patients will receive the treatment for 5 years. Follow-up will be for a minimum of 5 years after starting the study drug.

Sponsor(s): National Cancer Institute of Canada

Study Activation: 9-2-2005

IRB Review and Approval Date: 4-22-2005

Study Type: Prevention/Treatment

Projected Accrual: 4,560 patients

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Dr. Sandhya Pruthi

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623.


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/07/2008