New Reference: Trastuzumab Emtansine in HER2-Positive Breast Cancer with Residual Disease


  • Study

    Phase 3, multicenter, randomized, controlled trial (KATHERINE)
    HER2-positive early breast cancer with residual invasive cancer after neoadjuvant therapy
    T-DM1 vs. trastuzumab (14 cycles every 3 weeks)



  • Efficacy

    7-yr IDFS: 80.8% vs. 67.1% (T-DM1 vs. trastuzumab) (HR: 0.54 [0.44-0.66])
    Distant recurrence: 14.7% vs. 21.5%
    CNS recurrence (first invasive-disease event): 7.0% vs. 5.1%
    CNS recurrence (subsequent): 0.5% vs. 2.6%
    7-yr OS: 89.1% vs. 84.4% (HR: 0.66 [0.51-0.87], P=0.003)



  • Safety

    Grade ≥3 AEs: 26.1% vs. 15.7% (T-DM1 vs. trastuzumab)
    Serious AEs: 12.7% vs. 8.1%
    Cardiac and other toxic effects: Rare in both groups



  • N Engl J Med 2025;392:249-257

    Geyer CE,Untch M,Huang CS Survival with Trastuzumab Emtansine in Residual HER2-Positive Breast Cancer

    http://doi.org/10.1056/NEJMoa2406070

    Reviewed by Ulas D. Bayraktar, MD on Jan 24, 2025