A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

Trial Profile

A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2018

At a glance

  • Drugs Filgrastim (Primary)
  • Indications Febrile neutropenia
  • Focus Registrational; Therapeutic Use
  • Acronyms PIONEER
  • Sponsors Sandoz
  • Most Recent Events

    • 05 Jun 2018 Results assessing the safety and efficacy of biosimilar filgrastim in Breast Cancer patients from PIONEER (n=217) and MONITOR-GCSF (n=466) studies, presented at the 54th Annual Meeting of the American Society of Clinical Oncology
    • 28 Oct 2017 Results assessing the efficacy for pooled switched groups to the unswitched reference group (excluding patients who received biosimilar filgrastim alone continuously) during cycles 2-6, published in the Annals of Oncology Journal.
    • 06 Jun 2017 Results assessing safety profile of EP2006 from this and other EU registration trial (n=277) presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
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