IRB Number:

901-05

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done to:

Low/ Average Risk Patients:
1. Measure the level of certain hormones, enzymes and cellular products in urine and serum (blood) samples obtained from women who are low or average risk for developing breast cancer
2. Determine whether the level of these products present in urine and blood samples may be related to risk of developing breast cancer

High Risk/ Recently Diagnosed Breast Cancer Patients
1. Measure the level of certain hormones, enzymes and cellular products in breast nipple fluid samples, urine and serum (blood) samples obtained from women who are high risk for developing breast cancer and in women with a recent new diagnosis of breast cancer
2. Determine whether the level of these products present in urine, blood, and nipple fluid samples may be related to risk of developing breast cancer

Who is Eligible to Participate in the Study?

- Age 19 to 80
- No prior treatment with chemotherapy for breast or other cancers
- No prior history of advanced breast cancer
- No prior use of tamoxifen or raloxifene or aromatase inhibitor
- No estrogen or other hormone use currently or in the past three months
- No oral contraceptive use in the past three months

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

What is Involved With this Study?

1) Giving a urine and serum sample if low or average risk; OR
2) Giving a urine and serum sample and having the option to have the nipple aspirate procedure if high risk or recently diagnosed with breast cancer. If a patient agrees to have the nipple aspirate procedure, a health care provider in the Breast Clinic will perform the procedure to obtain a sample of breast nipple fluid.

How long will the Study run?

Patients' participation will be done after the urine and blood samples are collected.

Sponsor(s): Mayo Clinic, Eppley Institute for Research in Cancer

Study Activation/Registration Date: 05/20/2005

IRB Review and Approval Date: 04/26/2005

Study Type: Diagnostic

Projected Accrual: The plan is to have up to 460 patients participate at Mayo Clinic.

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

Principal Investigator: Sandhya Pruthi, MD

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

Last updated: 05/23/2008