A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer

摘要: Background: The safety and efficacy of neratinib monotherapy were compared with that lapatinib plus capecitabine in patients human epidermal growth factor receptor-2- positive (HER2+), locally advanced/metastatic breast cancer prior trastuzumab treat- ment. Methods: Patients received 240 mg/d continuously (n = 117) or 1250 2000 mg/m 2 per day on days 1-14 each 21-d cycle 116). primary aim was to demonstrate non-inferiority for progression-free survival (PFS). Findings: not demonstrated when lapat- inib (hazard ratio, 1.19; 95% confidence interval, 0.89-1.60;