DESTINY-Breast09

NCT04784715 📎

Regimen

Experimental
Trastuzumab deruxtecan (T-DXd) + pertuzumab (and placebo for control).
Control
Taxane + trastuzumab + pertuzumab (the CLEOPATRA regimen).

Population

HER2-positive metastatic or unresectable breast cancer, first-line therapy, hormone receptor positive or negative.

Key finding

DESTINY-Breast09 displaced the 13-year CLEOPATRA standard with T-DXd + pertuzumab as new 1L option for HER2+ MBC. NCCN v2.2026 category 1 (new this cycle). OS data maturing; ILD remains principal safety concern.

Source: PMID 41160818

Timeline

  • Publication: 2026 Feb 5

Guideline citations

  • NCCN BREAST