HER2+ advanced breast cancer: trastuzumab emtansine best for patients unsuitable for taxane therapy

  • Perez EA & al.
  • Cancer
  • 18 Jul 2019

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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  • The final phase 3 results from MARIANNE show that trastuzumab emtansine (T-DM1) with or without pertuzumab has similar OS compared with trastuzumab with taxane among patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (aBCa).
  • T-DM1 without pertuzumab (T-DM1+placebo) displayed greater tolerability.

Why this matters

  • Previous results showed similar PFS across groups and greater tolerability of T-DM1+placebo.
  • Authors conclude that T-DM1 is a first-line treatment for patients with metastatic HER2+ BCa who are considered unsuitable for taxane-based therapy.

Study design

  • 1095 women in 38 countries were randomly assigned to T-DM1+placebo, T-DM1+pertuzumab, or taxane+trastuzumab (control group).
  • OS was the primary outcome.
  • Funding: F. Hoffmann-La Roche, Ltd.

Key results

  • Median follow-up was approximately 54 months.
  • Median OS was no different across groups (T-DM1+placebo, 53.7 months; T-DM1+pertuzumab, 51.8 months; and control group, 50.9 months). Compared with control, T-DM1+placebo had stratified HR, 0.93; 97.5% CI, 0.73-1.20 and T-DM1+pertuzumab had stratified HR, 0.86; 97.5% CI, 0.67-1.11.
  • The median time to clinically meaningful deterioration in neurotoxicity symptoms was shorter in the control group (2.1 months) and T-DM1+pertuzumab group (4.2 months) than the T-DM1+placebo group (6.2 months).
  • The T-DM1+placebo group had lower rates of alopecia, diarrhea, and fewer treatment-related adverse events.


  • None were reported by the authors.


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