NSABP B-43: A Phase III Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
March 14, 2009
Cancer - Breast
Principal Investigator: Thomas J Doyle, MD
The purpose of this research study is 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 ductal carcinoma in situ (DCIS).
Patients must be female; Patients must be 18 years of age or older; On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) (Patients with mixed DCIS and lobular carcinoma in situ [LCIS] are eligible; The interval between the last surgery for excision of DCIS (lumpectomy or reexcision of lumpectomy margins) and randomization must be no more than 120 days.