B43 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
This research is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called HerceptinÂ®) to breast radiation therapy for the treatment of very early stage breast cancer called ductal carcinoma in situ (DCIS).
Females 18 years or older with the following, but not limited to, may be eligible to participate: Ductal carcinoma in situ (DCIS) without invasive breast cancer; Undergone a lumpectomy with clear margins; No involvement of the nodes; Involving only the one breast; No prior history of breast cancer; No cardiac disease; No uncontrolled high blood pressure; and Not pregnant or breastfeeding.
Eligible patients will be randomized, like flipping a coin, to receive either radiation therapy (RT) alone or two doses of trastuzumab given concurrently with RT. The RT must be whole breast irradiation (with or without a boost) delivered over 5-6 weeks or, at the investigator's discretion, accelerated fractionation may be used. For patients with DCIS that is hormone receptor-positive, hormonal therapy should be given for a minimum of 5 years. Selection of the hormonal therapy agent(s) is at the discretion of the investigator. Approximately 2000 patients will participate in the study over a period of 8 years.
07/24/2014 04:10 AM