- 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.
- 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.
- 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.
- No control group.
- Nonrandomized, observational design.