Early Stage Breast Cancer
This study is studying breast cancer patients with an early stage of breast cancer called ductal carcinoma in situ (DCIS). DCIS is also known as intraductal or non-invasive breast cancer. This study is for breast cancer patients who have a type of cancer called ÒHER2-positiveÓ. HER2-positive means that the cancer makes too much of a protein called HER2. The purpose of this study is to find out if adding a drug called trastuzumab to breast radiation therapy will be more effective than radiation therapy without trastuzumab in treating DCIS.
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 patients with DCIS. This study will find out if adding 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 patients with HER2-positive DCIS. You will be randomized (selected by chance) into one of the study groups, either you will receive radiation therapy ( radiation therapy after a lumpectomy is part of regular cancer care for DCIS) or you will receive 2 doses of trastuzumab during the time period you receive radiation therapy. You will continue to be followed up for 15 years with periodic mammographies and doctor visits.
You must have the diagnosis of DCIS and your tumor sample must be tested by the study to determine that it is HER-2 positive. All of the DCIS must have been removed by lumpectomy.
Harry Staszewski, MD
Patricia Ly RN MSN ANP firstname.lastname@example.org