IRB Number:

1433-05

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. The purpose of this study is to see if partial breast irradiation (PBI) is as good as or better than whole breast irradiation (WBI) in keeping cancer from coming back in the breast. WBI is a standard treatment after a lumpectomy. WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. PBI is radiation therapy given only to the area of the breast where the cancer was removed. PBI is given 2 times a day on 5 days. PBI may be given over a period of 5 to 10 days. There are 2 different methods of PBI that are being used in this study: multi-catheter brachytherapy and 3-D conformal external beam irradiation.

Who is Eligible to Participate in the Study?

Patients diagnosed with breast cancer and having already had a lumpectomy to remove the cancer.

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

What is Involved With this Study?

Physical exams

• Chest x-ray or chest CT (computed tomography, a type of x-ray)


• Mammogram


• Breast exam


• CT scan of the breast that had the cancer to help plan radiation therapy


• Blood tests


• Possible pregnancy test for women potentially able to have children


• Radiation therapy

How long will the Study run?

Patients will be asked to visit the study physician for follow-up exams for at least 5 years and to have yearly mammograms for the rest of their life.

Sponsor(s): Clinical Trials Support Unit of the National Cancer Institute (CTSU); National Surgical Adjuvant Breast and Bowel Project (NSABP); Radiation Therapy Oncology Group (RTOG)

Study Activation: 09/16/2005

IRB Review and Approval Date: 08/04/2005

Projected Accrual: 150

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

Principal Investigator: Dr. Ivy Petersen

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