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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Age 18-75 years old (including both ends), female.
• Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
• Expected survival ≥ 12 weeks.
• Have adequate renal and hepatic function.
• Patients voluntarily joined the study and signed the informed consent.
Locations
Other Locations
China
Peking University Cancer Hospital
RECRUITING
Beijing
Cancer Hospital，Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Tingting Lei
tingting.lei.tl6@hengrui.com
+86-0518-82342973
Time Frame
Start Date: 2025-08-20
Estimated Completion Date: 2028-12
Participants
Target number of participants: 400
Treatments
Experimental: SHR-A1811 and SHR-1316 Group
Active_comparator: Toripalimab and Nab-paclitaxel Group
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.