A randomized, 3 arm, multicentre, phase III study to evaluate the efficacy and the safety of T-DM1 combined with Pertuzumab or T-DM1 combined with Pertuzumab-Placebo, versus the combination of Herceptin plus taxane, as first line treatment in HER2 positive progressive or recurrent locally advanced or metastatic breast cancer

Trial Profile

A randomized, 3 arm, multicentre, phase III study to evaluate the efficacy and the safety of T-DM1 combined with Pertuzumab or T-DM1 combined with Pertuzumab-Placebo, versus the combination of Herceptin 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: 02 Jun 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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