Dalian Wanchun Biotechnology Co. Ltd.

Duration of severe neutropenia during Cycle 1 was compared in patients with early-stage (stage I and II) and stage III breast cancer (node-positive or node-negative at high risk of recurrence). Assess absolute neutrophil counts at screening (before TAC administration in Cycle 1) and on Cycle 1 Days 1, 2, 3, 6, 7, 8, 9, 10, 11, 12, 13, and 15 (before dosing on dosing day; other days are roughly equivalent to before dosing on dosing day).

The primary objective was to assess the duration of severe neutropenia in docetaxel plus plinabulin versus docetaxel plus pegfilgrastim during cycle 1. Secondary objectives were bone pain, the incidence of neutropenia, the incidence of infections, the incidence of febrile neutropenia, and the incidence and duration of hospitalizations due to neutropenia.

Determine the Phase III recommended dose (RP3D) based on pharmacokinetic (PK)/pharmacodynamic (PD) analysis