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trial handovered to another sponser.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS001 Plus Nab-Paclitaxel | Experimental | Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity. |
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| Placebo Plus Nab-Paclitaxel | Placebo Comparator | Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS001，an engineered anti-PD-1 antibody | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JIANG ZE FEI, PHD | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The fifth medical center of PLA general hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38191615 | Derived | Jiang Z, Ouyang Q, Sun T, Zhang Q, Teng Y, Cui J, Wang H, Yin Y, Wang X, Zhou X, Wang Y, Sun G, Wang J, Zhang L, Yang J, Qian J, Yan M, Liu X, Yi T, Cheng Y, Li M, Zang A, Wang S, Wang C, Wu X, Cheng J, Li H, Lin Y, Geng C, Gu K, Xie C, Xiong H, Wu X, Yang J, Li Q, Chen Y, Li F, Zhang A, Zhang Y, Wu Y, Nie J, Liu Q, Wang K, Mo X, Chen L, Pan Y, Fu P, Zhang H, Pang D, Sheng Y, Han Y, Wang H, Cang S, Luo X, Yu W, Deng R, Yang C, Keegan P. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2024 Jan;30(1):249-256. doi: 10.1038/s41591-023-02677-x. Epub 2024 Jan 8. |
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|
| Nab-Paclitaxel | Drug | 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. |
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| Placebo | Drug | Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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) | 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) |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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