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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: 13 Jun 2019

At a glance

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

    • 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.
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