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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)

NCT01772472 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1486

Last updated 2025-07-22

Study results available
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Summary

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.

Conditions

Interventions

DRUG

trastuzumab

6 mg/kg intravenously every 3 weeks, 14 cycles

DRUG

trastuzumab emtansine

3.6 mg/kg intravenously every 3 weeks, 14 cycles

Sponsors & Collaborators

  • NSABP Foundation Inc

    collaborator NETWORK

  • GBG Forschungs GmbH

    collaborator OTHER

  • Hoffmann-La Roche

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-03
Primary Completion
2018-07-25
Completion
2024-05-23

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Czechia
  • France
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Ireland
  • Israel
  • Italy
  • Mexico
  • Panama
  • Peru
  • Serbia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01772472 on ClinicalTrials.gov