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A Randomized, Open Label, Multicenter Phase IIIb Study Comparing Two Trastuzumab Dosing Regimens, Each in Combination With Cisplatin/Capecitabine Chemotherapy, as First-Line Therapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Adenocarcinoma Who Have Not Received Prior Treatment for Metastatic Disease

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Trial Profile

A Randomized, Open Label, Multicenter Phase IIIb Study Comparing Two Trastuzumab Dosing Regimens, Each in Combination With Cisplatin/Capecitabine Chemotherapy, as First-Line Therapy in Patients With HER2-Positive Metastatic Gastric or Gastro-Esophageal Junction Adenocarcinoma Who Have Not Received Prior Treatment for Metastatic Disease

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Trastuzumab (Primary) ; Capecitabine; Cisplatin
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms HELOISE
  • Sponsors Roche

    • Most Recent Events

    • 01 Aug 2017 Primary endpoint (Overall Survival - FAS) has not been met as per the results published in the Journal of Clinical Oncology
    • 05 Oct 2016 Status changed from completed to discontinued.
    • 20 Apr 2016 Interim results (n=248) presented at the 107th Annual Meeting of the American Association for Cancer Research
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