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Objective:To assess the long-term effectiveness and safety of trastuzumab in adjuvant therapy for Chinese patients with early-stage human epidermal growth factor 2 (HER2)-positive breast cancer in a real-world setting.Methods:This retrospective observational study analyzed the medical records of HER2-positive breast cancer patients between 2000 and 2012 at the Chinese Academy of Medical Sciences.Patients who received adjuvant chemotherapy alone or adjuvant chemotherapy followed by/combined with trastuzumab were included.The Kaplan-Meier method was used to estimate disease-free survival (DFS) and overall survival (OS).Hazard ratios (HR) and 95％ confidence intervals (95％ CI) were calculated using the Cox regression model.Results:Of the 1,348 patients analyzed,909 received chemotherapy alone and 439 received chemotherapy plus trastuzumab.The 3-year,5-year and 10-year DFS rates were 83.70％,76.38％ and 68.94％,respectively,in the chemotherapy-alone cohort,and 90.21％,86.19％ and 83.45％ in the chemotherapy plus trastuzumab cohort.The 3-year,5-year and 10-year OS rates were 96.10％,91.40％ and 81.88％ in the chemotherapy-alone cohort,and 98.17％,94.91％ and 90.01％ in the chemotherapy plus trastuzumab cohort.The chemotherapy plus trastuzumab group had a significantly lower risk of disease recurrence and death than the chemotherapy-alone group (DFS:HR=0.50,95％ CI,0.37-0.68;P＜0.001;OS:HR=0.53,95％ CI,0.34-0.81;P=0.004) after adjusting for covariates.In the 439 patients treated with trastuzumab,multivariate analysis suggested that lymph node positivity,higher T stages,and hormone receptor-negative status were significandy associated with higher risks of disease recurrence,and lymph node positivity and hormone receptor-negative status were significantly associated with higher risks of death.Grade 3/4 adverse events (incidence ≥1％) were more common in patents receiving trastuzumab (54.44％ vs.15.73％).Conclusions:Early-stage HER2-positive breast cancer patients treated with trastuzumab plus adjuvant chemotherapy have a significant survival benefit compared with chemotherapy-alone in real-world settings.Lymph node positivity,hormone receptor-negative status,and higher T stages may be associated with higher risks of recurrence,and effective therapy for patients with these factors is required.