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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
SHR-A1811 for injection.
SHR-1316 injection.
Toripalimab injection.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital,Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGProgression free survival (PFS)
Time frame: An average of 3 year.
Overall response (OS) rate evaluated by investigators
Time frame: An average of 3 year.
Clinical benefit rate (CBR) evaluated by investigators
Time frame: An average of 3 year.
Duration of response (DoR) evaluated by investigators
Time frame: An average of 3 year.
Progression-free survival on next-line therapy (PFS2) evaluated by investigators
Time frame: An average of 3 year.
Adverse events (AEs)
Time frame: An average of 3 year.
Serious adverse events (SAEs)
Time frame: An average of 3 year.
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Paclitaxel for injection.