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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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Jun 2019

At a glance

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

    • 04 Jun 2019 Results assessing patient reported outcomes (PRO's) presented at the 55th Annual Meeting of the American Society of Clinical Oncology.
    • 03 May 2019 According to a Genentech media release, Based on the data from this study, U.S. Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment.
    • 05 Feb 2019 According to a Roche media release, based on the results of this study, the company has submitted a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for Kadcyla (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (eBC) with residual disease after neoadjuvant (before surgery) treatment. The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programmes.
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