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A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

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A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Trastuzumab emtansine (Primary) ; Docetaxel; Paclitaxel
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms GATSBY
  • Sponsors Chugai Pharmaceutical; Roche

    • Most Recent Events

    • 14 Dec 2019 Results from a a systematic review and meta-analysis of phase 3 randomized controlled trials (MARIANNE, GATSBY, and KRISTINE), to determine the relative risk of peripheral neuropathy and peripheral sensory neuropathy associated with T-DM1 comparing to taxane-based regimens presented at the 42nd Annual San Antonio Breast Cancer Symposium.
    • 14 Dec 2019 Results of systematic review and meta-analysis of phase 3 randomized controlled trials (EMILIA, GATSBY, KRISTINE, MARIANNE, and TH3RESA) presented at the 42nd Annual San Antonio Breast Cancer Symposium
    • 14 Dec 2019 Results of systemic review and meta analysis assessing Relative risk of grade 3 and higher hematological toxicities with trastuzumab emtansine presented at the 42nd Annual San Antonio Breast Cancer Symposium

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