The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Participants will be randomized in a 1:1 ratio to Arm A (camrelizumab +chemotherapy) or Arm B (placebo + chemotherapy).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
441
camrelizumab+chemotherapy
placebo+chemotherapy
Fudan University Cancer Hospital
Shanghai, China
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery.
Time frame: Up to approximately 24 weeks
Event-free Survival (EFS) as assessed by Investigator.
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Time frame: At least 2 years
Disease-free Survival (DFS) as assessed by Investigator
DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.
Time frame: At least 2 years
Distant Disease-free Survival (DDFS) as assessed by Investigator
DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
Time frame: At least 2 years
Objective response rate (ORR) in accordance with RECIST v1.1
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.
Time frame: Up to approximately 24 weeks
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 67 weeks
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