The Absolute Effect / Evidence index

Advanced / Metastatic · Randomized clinical trial; N=551; ERBB2-low advanced breast cancer. Trastuzumab rezetecan 6.4 mg/kg q3w vs physician-choice chemotherapy. Primary endpoint BICR PFS in chemotherapy-naive and overall populations. · Overall median PFS 16.4 vs 6.8 months

HORIZON-Breast06

Clinical question: Does trastuzumab rezetecan improve PFS over physician-choice chemotherapy in ERBB2-low advanced breast cancer?

Overall median PFS 16.4 vs 6.8 months; HR 0.27 (95% CI 0.21–0.34; P<0.001). Chemotherapy-naive PFS 16.6 vs 6.8 months; HR 0.25. · Registry:

Design, population and treatment

Randomized clinical trial; N=551; ERBB2-low advanced breast cancer. Trastuzumab rezetecan 6.4 mg/kg q3w vs physician-choice chemotherapy. Primary endpoint BICR PFS in chemotherapy-naive and overall populations.

Key efficacy outcome

16.4 · intervention
6.8
16.4 · comparator
Not calculable from median PFS; approximate NNH 7 for grade ≥3 treatment-related AEs (16.2-point increase).

Grade ≥3 treatment-related AEs 84.1% vs 67.9%, chiefly neutrophil-count decrease.

Safety and absolute effect

Median PFS (months)

https://jamanetwork.com/journals/jama/article-abstract/2855791

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: 10.1001/jama.2026.21372