Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer

This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.

Inclusion Criteria:female;aged ≥ 18 years and ≤75 years;histologically proved metastatic HER-2 negative breast cancer. HER2-negative status determined by situ hybridization (FISH) or immunohistochemistry (IHC) (IHC 0, 1+, 2+ and/or FISH HER2 negative);at least one measurable or evaluable lesion based on RECIST 1.1 criteria;estimated life expectancy ≥ 3 months;normal heart, liver, and kidney function;Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;informed consent signed by the participantsExclusion Criteria:received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation;participated in other new drug clinical trials within 4 weeks before enrollment;inflammatory breast cancer;symptomatic visceral disease;second primary malignancy;mental disorder.