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A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Summary
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).
Official title: A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-08-20
Completion Date
2028-12
Last Updated
2025-12-18
Healthy Volunteers
No
Interventions
SHR-A1811 for Injection
SHR-A1811 for injection.
SHR-1316 Injection
SHR-1316 injection.
Toripalimab Injection
Toripalimab injection.
Paclitaxel for Injection
Paclitaxel for injection.
Locations (2)
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital,Fudan University
Shanghai, Shanghai Municipality, China