Advanced / Metastatic · Phase III multicentre open-label randomized; N=885 HER2-positive advanced breast cancer. Anbenitamab+HB1801 vs docetaxel-trastuzumab-pertuzumab. Primary endpoint BICR PFS. · 24-month PFS 58.5% vs 34.4%

HEALER

Clinical question: Does anbenitamab plus HB1801 improve PFS over docetaxel-trastuzumab-pertuzumab in first-line HER2-positive advanced breast cancer?

24-month PFS 58.5% vs 34.4%; HR 0.46 (95% CI 0.37–0.56; P<0.001); absolute gain 24.1 points; NNT 5. ORR 87.6% vs 73.4%. · Registry:

Design, population and treatment

Phase III multicentre open-label randomized; N=885 HER2-positive advanced breast cancer. Anbenitamab+HB1801 vs docetaxel-trastuzumab-pertuzumab. Primary endpoint BICR PFS.

Key efficacy outcome

58.5 · intervention

34.4

58.5 · comparator

NNT 5 for one additional patient progression-free at 24 months; approximate NNH 9 for grade ≥3 AEs.

Grade ≥3 AEs 45.9% vs 34.4%; neutropenia common; two adverse-event deaths per group.

Safety and absolute effect

24-month PFS (%)

https://www.nejm.org/doi/10.1056/NEJMoa2610345

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1056/NEJMoa2610345