NSABP B43: Trastuzumab + Radiation or Radiation Alone for HER2+ DCIS
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 is a '2-step randomization'. Step 1-HER2 testing on the tissue taken at the time of biopsy or surgery for HER2 positive or negative DCIS.
If negative, patients do not proceed to Step 2. If positive, patients are randomized (ie: coin toss) to receive either radiation therapy alone, or radiation + 2 doses of trastuzumab for the treatment of their DCIS.
There are numerous Inclusion and Exclusion criteria for this trial. Potential participants must meet all of the criteria to be eligible for the trial.