In a phase III study of HER2-positive advanced or metastatic breast cancer refractory to anthracyclines, taxanes, and trastuzumab, lapatinib plus capecitabine showed a significant advantage over capecitabine monotherapy with respect to ORR and PFS with a nonsignificant trend toward longer OS [ 67 ].
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Median TTP was two months longer in the combination arm, but did not reach statistical significance.