SHR-A1811-102

NCT04513223 📎

Regimen

Experimental
Trastuzumab rezetecan (SHR-A1811) 4.8 mg/kg IV q3w (single-arm phase 1/2 expansion).
Control
N/A (single-arm)

Population

HER2-positive metastatic breast cancer previously treated with trastuzumab and taxane; included post-T-DM1 patients and brain metastasis subset.

Key finding

SHR-A1811 showed T-DXd-class activity in HER2+ MBC with potentially lower ILD signal. Data supported breakthrough designation and phase 3 HER2-CLIMB-type studies. NMPA accepted NDA; acts as Chinese analogue to T-DXd in the post-trastuzumab 2L/3L HER2+ landscape.

Timeline

    Guideline citations

    • NCCN BREAST