Phase II study of lapatinib in combination with vinorelbine in patients with HER2 positive recurrent or metastatic breast cancer: a multicentric Turkish Oncology Group (TOG) trial.

摘要: Abstract Background The aim of this explorative phase II study was to evaluate the activity and safety lapatinib in combination with intravenous vinorelbine women HER2 positive metastatic or recurrent breast cancer. Methods Twenty-nine patients were enrolled. primary objectives response clinical benefit (CB) rates, secondary toxicity, duration progression free survival. Patients received 1250 mg oral continuously once daily 20–25 mg/m 2 on days 1 8, every 3 weeks. Results Although 25 evaluable for response, according intend treat analysis 28 patients; 14% had confirmed partial (PR) 36% stable disease more than 24 weeks a CB rate 50%. Sixty four percent suffered from grade 3–4 hematologic 18% extra-hematologic toxicities. Conclusion results trial provide evidence further investigate potential unsuitable trastuzumab who become refractory trastuzumab.