IRB Number:

999-05

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to examine how a woman's genes affect the way her body responds to anastrozole treatment. Researchers will look at changes in hormone levels, bone density and mammograms.

Who is Eligible to Participate in the Study?

Women diagnosed with breast cancer and will be starting anastrozole (Arimidex) as part of their initial treatment.

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

What is Involved With this Study?

Blood samples will be collected from 1000 breast cancer patients who are receiving their initial treatment with anastrozole as part of their standard clinical management. One sample will be taken before the start of treatment, one sample will be taken 6  12 weeks after start of treatment, and a final sample will be taken after 1 year. Breast density will be measured by a mammogram done after starting treatment with anastrozole and form a mammogram done after one year on anastrozole. Bone density will be measured before starting treatment with anastrozole and another measurement done after one year on anastrozole. Researchers will evaluate how a persons genes change the effect that treatment with anastrozole has on breast density and bone density.

How long will the Study run?

Patients may be in the study for up to one year.

Sponsor(s): Mayo Clinic and MD Anderson

Study Activation: 07/29/2005

IRB Review and Approval Date: 05/19/2005

Projected Accrual: 500

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

Principal Investigator: Dr. James Ingle

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, or e-mail cancerclinicaltrials@mayo.edu


• 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
• Jacksonville, FL

Last updated: 01/09/2009