This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
375
JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
The fifth medical center of PLA general hospital
Beijing, China
Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
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: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)
Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
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: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
Time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.
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Time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
Time frame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
OS rate at 12 months
OS is defined as the time from randomization to death from any cause.
Time frame: the percent of participants that are alive at 12months from Day 1.
OS rate at 24 months
OS is defined as the time from randomization to death from any cause.
Time frame: the percent of participants that are alive at 24 months from Day 1.
PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.
Time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.
Time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.
Time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.
Time frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
Percentage and severity of Participants With Adverse Events (AEs)
percentage and CTC AE(v5.0) of AEs
Time frame: From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
Percentage of Participants With Anti-Drug Antibodies (ATAs)
Time frame: Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)