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Clinical trial

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)

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Last updated:3rd Apr 2013
Identifier: NCT01772472

This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 1487 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: April 3, 2013
Actual Primary Completion Date: July 25, 2018
Estimated Study Completion Date: April 4, 2023

Arms:
- Active Comparator:
Trastuzumab
- Experimental: Trastuzumab emtansine

Category Value
Date last updated at source 2019-06-04
Study type(s) Interventional
Expected enrolment 1487
Study start date 2013-04-03
Estimated primary completion date 2018-07-25

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