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A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy

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Trial Profile

A Phase III Randomized, Multicenter, Two Arm, Open-label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2-positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2022

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At a glance

  • Drugs Trastuzumab emtansine (Primary) ; Antineoplastics; Capecitabine; Docetaxel; Gemcitabine; Paclitaxel; Tamoxifen; Trastuzumab; Vinorelbine
  • Indications Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TH3RESA
  • Sponsors Roche

Most Recent Events

  • 07 Jan 2020 Results of an individual patient-level data pooled analysis of trials testing T-DM1 in the advanced setting investigating T-DM1-induced cardiotoxicity, with a focus on the incidence of CEs, clinical presentation of CEs, impact on treatment continuity, reversibility as well as in any potential risk factors that could aid in patient selection and follow-up published in the European Journal of Cancer
  • 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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