A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared with Trastuzumab in Subjects with HER2 Positive Early Breast Cancer

Trial Profile

A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared with Trastuzumab in Subjects with HER2 Positive Early Breast Cancer

Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Trastuzumab (Primary) ; Cyclophosphamide; Epirubicin; Paclitaxel
  • Indications Early breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms Lilac
  • Sponsors Amgen
  • Most Recent Events

    • 31 Jul 2017 According to an Amgen media release, the company has submitted a Biologics License Application (BLA) to the US FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab). The BLA submission includes data from this trial and analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data.
    • 03 Feb 2017 Status changed from active, no longer recruiting to completed.
    • 13 Nov 2016 This trial has been completed in Czech Republic as per European Clinical Trials Database record.
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