A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

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Trial Profile

A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2017

At a glance

  • Drugs Pertuzumab (Primary) ; Trastuzumab emtansine (Primary) ; Docetaxel; Paclitaxel; Trastuzumab
  • Indications Advanced breast cancer; Male breast cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MARIANNE
  • Sponsors Chugai Pharmaceutical; Roche

    • Most Recent Events

    • 02 Jun 2017 Final overall survival (OS) and safety results from this study (data cut off: 15 May, 2016), presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 10 Jan 2017 Results published in the Journal of Clinical Oncology
    • 10 Jan 2017 This trial has been completed in Sweden (end date: 2016-09-16), according to European Clinical Trials Database.
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