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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2024

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At a glance

  • Drugs Pertuzumab (Primary) ; Trastuzumab emtansine (Primary) ; Docetaxel; Paclitaxel; Trastuzumab
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 positive breast cancer; Male breast cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms MARIANNE
  • Sponsors Chugai Pharmaceutical; 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
    • 16 Dec 2019 Bulgaria, China, Costa rica, Latvia, Lithuania were in the planned locations.
    • 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.
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