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Number: CTSU B-43 Principal Investigator: Zoberi, Imran
Title: 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
Phase: III Disease Site: Breast, Female
Participating Site(s):
 
Main Campus
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South County
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St. Peters
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West County
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Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
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.
In this study, trastuzumab is considered to be investigational (still being researched) because it has not yet been approved by the U.S. Food and Drug Administration (FDA) or Health Canada for use in the treatment of DCIS.
This study will learn if trastuzumab given without chemotherapy affects the ovaries in women who have not yet gone through menopause.
 
More Information:
ClinicalTrials.gov Entry
Internal Protocol Documents (requires Siteman administrative database password)