Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy

Trial Profile

Multicenter, Double-Blind, Randomized, Comparative Efficacy and Safety Study of MYL-1401H and European Sourced Neulasta® in Stage II/III Breast Cancer Patients Receiving Neoadjuvant or Adjuvant Chemotherapy

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Nov 2016

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Breast cancer
  • Focus Therapeutic Use
  • Sponsors Mylan
  • Most Recent Events

    • 30 Nov 2016 New trial record.
    • 11 Oct 2016 Primary endpoint (Mean Duration of Severe Neutropenia (DSN), defined as consecutive days with absolute neutrophil count (ANC) 0.5 109/L) has been met according to the results presented at the 41st European Society for Medical Oncology Congress.
    • 11 Oct 2016 Results presented at the 41st European Society for Medical Oncology Congress.
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