Efficacy and Safety Study With MYL-1401H and Neulasta

After successful screening, eligible patients will be randomly allocated to one of the two study arms, either receiving MYL-1401H or Neulasta. Randomization is 2:1 to MYL-1401H or Neulasta, respectively. Subjects will receive first of six cycles of background therapy (Docetaxel, Doxorubicin, Cyclophosphamide \[TAC\]) on day 1. Treatment with study drug (either MYL-1401H or Neulasta) is scheduled on Day 2 of each cycle, at least 24 hours after chemotherapy administration. Duration of each cycle is 3 weeks. Follow-up visit is scheduled 24 weeks after the first administration of study drug.