Contact:Katie Sullivan
Phone:(434)243-7231
E-mail:kls8d@virginia.edu
UVa Health System, Department of Radiation Oncology seeks women, age 18 or older, who have been diagnosed with breast cancer for a research study. The tumor must be ductal carcinoma in situ (DCIS). DCIS is also known as 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.
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.
The drug trastuzumab is called a targeted therapy because it targets breast cancers that make too much of the protein called HER2. These cancers are called HER2-positive. Too much of the HER2 protein can cause cells to receive extra growth signals. This can turn a normal cell into a cancer cell and can cause cancer cells to grow faster.
Participants in this study must agree to special research tests on tumor tissue that was removed at the time of their lumpectomy. The results of these tests will confirm that the tumor is HER2-positive and should provide researchers with information about how genes in the cancer cells may affect the way HER2-positive DCIS responds to treatment.
This is a randomized study. Participants will have an equal chance of being registered to one of the two following groups:
Group 1 will receive radiation therapy.
Group 2 will receive radiation therapy and two intravenous doses of trastuzumab during the time period they are receiving radiation therapy.
Study treatment will last about 3-6 weeks depending on the prescribed radiation therapy treatment schedule.
No compensation is provided for this study.
Contact Information:
For more information please contact:
" Katie L. Sullivan, MSW, CCRC
" 434-243-7231, kls8d@virginia.edu
" Insert IRB-HSR # 14464
Principal Investigator: Paul Read, MD
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Primary Investigator: Read Paul, W