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: 13 Jun 2019
At a glance
- Drugs Trastuzumab (Primary) ; Cyclophosphamide; Epirubicin; Paclitaxel
- Indications Early breast cancer
- Focus Registrational; Therapeutic Use
- Acronyms LILAC
- Sponsors Amgen
- 13 Jun 2019 According to an Amgen Media release, Amgen and Allergan plc announced that the U.S. Food and Drug Administration(FDA) has approved KANJINTI™(trastuzumab-anns) for all approved indications of the reference product, Herceptin(trastuzumab) for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
- 04 Jun 2019 Results of an analysis comparing cardiac safety of ABP 980 and trastuzumab reference product (RP) in women with HER2-positive early breast cancer, were presented at the 55th Annual Meeting of the American Society of Clinical Oncology.
- 04 May 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History