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A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

Trial Profile

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2019

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At a glance

  • Drugs Trastuzumab emtansine (Primary) ; Trastuzumab
  • Indications Carcinoma; Early breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KATHERINE
  • Sponsors Roche
  • Most Recent Events

    • 18 Nov 2019 According to an Roche media release, data from this study will be presented at the San Antonio Breast Cancer Symposium (SABCS).
    • 15 Nov 2019 According to a Roche media release, based on the positive recommendation, a final decision regarding approval of Kadcyla in this setting, along with the full details of the approved indication, is expected from the European Commission in the near future.The recommendation from the CHMP is based on results from this phase III (KATHERINE) study.
    • 15 Nov 2019 According to a Roche media release, the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kadcyla (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy.
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