A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer

Trial Profile

A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Trastuzumab emtansine (Primary) ; Carboplatin; Docetaxel; Pertuzumab; Trastuzumab
  • Indications Early breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KRISTINE
  • Sponsors Roche
  • Most Recent Events

    • 23 Nov 2017 Primary endpoint (Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples) has not been met, according to results published in the Lancet Oncology Journal.
    • 23 Nov 2017 Results assessing the efficacy, safety, and patient-reported outcome data from the neoadjuvant phase of the trial, published in the Lancet Oncology Journal.
    • 29 Sep 2017 Planned End Date changed from 1 Jan 2018 to 31 Mar 2018.
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