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

StatusRecruiting
PhasePhase 3
Started2025-08-20
View on ClinicalTrials.gov ↗

Amendment history

2025-12-17
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09→confirmed 2025-08-20
Study sitesdetails revised at 2 of 2 sites
2025-08-01
minor
Original filing
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).
Trial Details
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