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
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
- 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.