Trial Information

NSABP B-43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

You are being asked to take part in this study because you have a very early stage of breast cancer called ductal carcinoma in situ (DCIS). DCIS is also known as intraductal or non-invasive breast cancer. DCIS means that the cancer cells are only in the milk ducts in the breast and have not spread to other breast tissue or to other parts of the body. You are being asked to take part in this study because you have had a lumpectomy to remove the DCIS, and you will be having breast radiation therapy. This study is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy. Radiation therapy is the standard treatment for subjects with DCIS. This study is being done to find out if adding the drug called trastuzumab to breast radiation therapy is more effective than radiation therapy without trastuzumab in preventing occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body in subjects with HER2-positive DCIS. You will be in this study for 10 years. Your study therapy will last about 3-6 weeks depending on your radiation therapy treatment schedule. We would like to keep track of your health until 10 years after you joined the study.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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Research Center Information: City of Hope

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