A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer

This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).

NCT Number	NCT07111832
Lead Sponsor	Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions	PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
Enrollment	400 participants
Start Date	2025-08-20
Primary Completion	2028-03 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-18