Figure 1.

Trial profile

*Seven patients were found to be ineligible after randomisation (four had previous cancer or ductal carcinoma in situ treated with surgery and radiotherapy, two were HER2 negative, and one had primary cancer confined to the axilla). †11 patients were found to be ineligible after randomisation (seven had previous cancer or ductal carcinoma in situ treated with surgery and radiotherapy, one was HER2 negative, two had metastatic disease, and one had received >9 cycles of trastuzumab).