DESTINY-Breast01

NCT03248492 📎

Regimen

Experimental
Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg IV every 3 weeks (single-arm).
Control
N/A (single-arm).

Population

HER2-positive metastatic breast cancer with progression after T-DM1 (median 6 prior regimens).

Key finding

DESTINY-Breast01 launched the T-DXd era with an unprecedented ORR/PFS in heavily pretreated HER2+ MBC. FDA accelerated approval Dec 2019. Also raised the ILD/pneumonitis signal that defines T-DXd safety monitoring.

Source: PMID 31825192

Timeline

  • Publication: 2020 Feb 13

Guideline citations

  • NCCN BREAST