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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History