SHR-A1811-HER2low

NCT04742153 📎

Regimen

Experimental
Trastuzumab rezetecan (SHR-A1811) 4.8 mg/kg IV q3w (single-arm phase 2 expansion).
Control
N/A (single-arm)

Population

HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer previously treated with >=1 line of chemotherapy; HR+ subgroup required prior endocrine therapy.

Key finding

Extended SHR-A1811 activity into HER2-low MBC with ORR approaching DESTINY-Breast04 T-DXd performance. Supports ongoing phase 3 vs chemotherapy in HER2-low setting and positions SHR-A1811 as Chinese competitor across both HER2+ and HER2-low indications.

Timeline

    Guideline citations

    • NCCN BREAST