Eribulin fails phase 2 trial of residual invasive early breast cancer

  • Yardley DA & al.
  • Breast Cancer Res Treat
  • 14 Feb 2020

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • Eribulin failed to exceed target expectations for 2-year DFS in a phase 2 trial of residual invasive early breast cancer (eBCa).

Why this matters

  • Study authors do not recommend further development of eribulin for this population.

Study design

  • Phase 2 prospective study of 3 cohorts receiving eribulin (1.4 mg/m2 intravenous [IV] on days 1 and 8 for 6 21-day cycles): triple-negative breast cancer (TNBCa; n=53), hormone receptor (HR)-positive/HER2-negative (n=42), and HER2-positive (n=31).
  • Patients had localized BCa and still had residual invasive cancer (in the breast or axilla) after ≥4 cycles of standard anthracycline and/or taxane-containing neoadjuvant chemotherapy.
  • 2-year DFS, the primary outcome, was compared against projections of benefit (based on studies of chemotherapy alone): TNBC (40%-56%), HR+/HER2 (80%-92%), and HER2+ (60%-75%).
  • Funding: Eisai.

Key results

  • Median follow-up was 28 months.
  • Each of the 3 cohorts did not significantly exceed projections with their 2-year DFS rate (95% CIs):
    • TNBC: 56% (42%-69%).
    • HR+/HER2: 83% (67%-91%).
    • HER2+: 73% (53%-86%).
  • The most frequent grade 3/4 treatment-related adverse events were neutropenia, leukopenia, and neuropathy.

Limitations

  • No control group.
  • Nonrandomized, observational design.