Overview

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)

Status:
Active, not recruiting

Trial end date:
2025-04-04

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Hoffmann-La Roche

Collaborators:

German Breast Group
NSABP Foundation Inc

Treatments:

Ado-Trastuzumab Emtansine
Maytansine
Trastuzumab