A Phase 2, Randomized, Open-Label, Study of Neratinib (HKI-272) vs Lapatinib Plus Capecitabine for 2nd/3rd-Line Treatment of HER2+ Locally Advanced or Metastatic Breast Cancer

摘要

Martin and associates presented the results from a .phase II, open-label study of neratinib. Neratinib is an orally active, irreversible pan-ErbB receptor tyrosine kinase inhibitor, targeted against HER2, HER1, and HER4. In a prior study of neratinib in patients with advanced or metastatic HER2-positive breast cancer, patients previously treated with trastuzumab showed an ORR of 24% and a median PFS of 22.3 weeks with neratinib monother-apy.2Patients who were trastuzumab-naive showed an ORR of 56% and a median PFS of 39.6 weeks. The most common adverse event was diarrhea.