Breast cancer: 6-month trastuzumab fails to demonstrate noninferiority

  • Lancet

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • 6 months of adjuvant trastuzumab was not noninferior to 12 months for preventing recurrence of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the final analysis of the PHARE trial.

Why this matters

Study design

  • Multicenter, open-label, phase 3 randomized controlled trial (n=3384) comparing 6 vs 12 months adjuvant trastuzumab.
  • All had nonmetastatic, operable, with either positive axillary nodes or negative axillary nodes but a tumor of ≥10 mm.
  • Primary outcome: DFS with a prespecified hazard margin of 1.15.
  • Funding: French National Cancer Institute.

Key results

  • Median follow-up was 7.5 (interquartile range [IQR], 5.3-8.8) years.
  • The 6-month group had 21.2% events relevant to DFS, whereas the 12-month group had 20.4%.
  • The aHR for DFS in the 12- vs 6-month group was 1.08 (95% CI, 0.93-1.25; P=.39). Because the prespecified noninferiority margin of 1.15 was included in the 95% CI, results were inconclusive regarding the noninferiority hypothesis.
  • No change in adverse events compared with earlier PHARE, including cardiac safety.

Limitations

  • Open-label design.

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