This multicenter, randomized, double-blind study will evaluate the efficacy and safety of Toripalimab (JS001) combined with nab-paclitaxel compared with placebo combined with nab-paclitaxel for first/second line treatment of metastatic or recurrent triple-negative breast cancer (TNBC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
531
JS001 240mg, i.v., q3w; Other name: Toripalimab
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Placebo, i.v., q3w;
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Intend to Treat patients.
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the BIRC using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Time frame: Up to approximately 61 months from first patient in.
PFS assessed by BICR using RECIST v1.1 in PD-L1 positive patients
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death due to any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Time frame: Up to approximately 61 months from first patient in.
Progression-Free Survival (PFS) assessed by investigator using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Time frame: Up to approximately 61 months from first patient in.
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Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Affiliated Hospital of Hebei University
Baoding, China
The first affiliated Hospital of Bengbu Medical College
Bengbu, China
Jilin Cancer Hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
Affiliated Hospital of Chengde Medical University
Chengde, China
...and 43 more locations
Objective response rate (ORR) assessed by BICR or investigators using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
ORR is defined as the rate of CR(Complete Response) or PR (Partial Response), as determined by BICR using RECIST v1.1
Time frame: Up to approximately 61 months from first patient in.
Duration of response (DoR) assessed by BICR or investigators using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
DoR is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.
Time frame: Up to approximately 61 months from first patient in.
Disease control rate (DCR) assessed by BICR or investigators using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
DCR is defined as the sum rate of CR, PR and SD (Stable Disease), as determined by BICR or investigators using RECIST v1.1
Time frame: Up to approximately 61 months from first patient in.
Overall Survival (OS). Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
OS is defined as the time from randomization to death from any cause
Time frame: Up to approximately 61 months from first patient in.
OS rate at 12 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
OS is defined as the time from randomization to death from any cause.
Time frame: Up to approximately 61 months from first patient in.
OS rate at 24 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
OS is defined as the time from randomization to death from any cause
Time frame: Up to approximately 61 months from first patient in.
Differences in safety and tolerability as assessed by the occurrence of adverse events. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months）
Time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 46 months）
Differences in the scores of disease/treatment-related symptoms evaluted by ECOG Performance Status. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
Evaluated by Eastern Cooperative Oncogloy Group (ECOG) Performance Status
Time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months)