Safety assessment
nausea, DLTs, neutropenia, fever, fatigue, diarrhea, thrombocytopenia, vomiting, anemia, heart and renal insufficiency
NEUTROPENIA, ADVERSE EVENTS, THROMBOCYTOPENIA, ANEMIA, BLEEDING TENDENCY
Safety was evaluated throughout the study. All adverse events (AEs) were recorded, the severity was assessed according to NCI‐CTCAE (V.4.0), and the relationship with pyrotinib or docetaxel was judged.DLT criteria included Grade 4 neutropenia with a duration of ≥7 days, Grade 3 or 4 neutropenia with fever, Grade 3 thrombocytopenia with bleeding tendency or Grade 4 thrombocytopenia, Grade 3 or 4 anemia; ≥ Grade 2 heart and renal insufficiency, Grade 3 or 4 non‐hematologic AE (except for Grade 3 fatigue lasting ≤3 days, recoverable diarrhea, nausea, and vomiting after supportive care). DLTs were assessed in 21 days following the first dose.