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Title:
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
Protocol Number:
ENSABPB43
Phase:
Phase III
Physician:
Deborah Armstrong
Purpose:
This research is being done to compare the effects, good and/or bad, of adding the drug trastuzumab (also called Herceptin®) to breast radiation therapy for the treatment of very early stage breast cancer called ductal carcinoma in situ (DCIS).
Eligibility:
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.
Treatment:
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.
Population:
Adult
Last Update
09/19/2014 04:03 AM
 

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