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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS001 Plus Nab-Paclitaxel | Experimental | Patients will receive both JS001 and Nab-Paclitaxel. |
|
| Placebo Plus Nab-Paclitaxel | Placebo Comparator | Patients will receive both placebo and Nab-Paclitaxel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS001 | Drug | JS001 240mg, i.v., q3w; Other name: Toripalimab |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to approximately 61 months from first patient in. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Metastatic or recurrent triple negative breast cancer (TNBC);
Exclusion Criteria:
Prior treatment with taxane as first line treatment;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Medical Center of PLA General Hospital | Beijing | Beijing Municipality | 100071 | China | ||
| Beijing Hospital |
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| Nab-Paclitaxel |
| Drug |
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w |
|
| Placebo | Drug | Placebo, i.v., q3w; |
|
| Nab-Paclitaxel | Drug | Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w |
|
| Up to approximately 61 months from first patient in. |
| 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 | 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. | 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 | 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 | 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. | 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 | 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） | 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 | From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months) |
| 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. | Up to approximately 61 months from first patient in. |
| 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 |
| Sichuan Cancer Hospital | Chengdu | China |
| Chongqing Cancer Hospital | Chongqing | China |
| The Second Hospital of Dalian Medical University | Dalian | China |
| The First People's Hospital of Foshan | Foshan | China |
| Fujian Medical University Union Hospital | Fuzhou | China |
| Guangdong General Hospital | Guangzhou | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | China |
| Sun Yat-sen University Cancer Center | Guangzhou | China |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | China |
| The Women and Children's Hospital of Guangdong Province | Guangzhou | China |
| The First Affiliated Hospital Zhejiang University | Hangzhou | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| Zhejiang Cancer Hospital | Hangzhou | China |
| Harbin Medical University Cancer Hospital | Harbin | China |
| Anhui Province Hospital & The First Affiliated Hospital of USTC | Hefei | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | China |
| The Second Hospital of Anhui Medical University | Hefei | China |
| The Affiliated Hospita of Inner Mongolia Medical University | Hohhot | China |
| Shandong Cancer Hospital | Jinan | China |
| Yunnan Cancer Hospital | Kunming | China |
| Linyi Cancer Hospital | Linyi | China |
| The Affiliated Hospita of of Southwest Medical University | Luzhou | China |
| Jiangxi Cancer Hospital | Nanchang | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | China |
| The Third Hospital of Nanchang | Nanchang | China |
| Jiangsu Cancer Hospital | Nanjing | China |
| Jiangsu Province Hospital | Nanjing | China |
| The Affiliated Hospital of Qingdao University | Qingdao | China |
| Changhai Hospital | Shanghai | China |
| Shanghai General Hospital | Shanghai | China |
| Liaoning Cancer Hospital&Intitute | Shenyang | China |
| The First Hospital of China Medical University | Shenyang | China |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | China |
| Cancer Hospital Affiliated to Xinjiang Medical University | Ürümqi | China |
| Hubei Cancer Hospital | Wuhan | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | China |
| Affiliated Hospital of Jiangnan University（Wuxi NO.4 People's Hospital） | Wuxi | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| The Second Affiliated Hospital of The PLA Air Force Military Medical University | Xi'an | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
| Xiangyang Central Hospital | Xiangyang | China |
| General Hospital of Ningxia Medical University | Yinchuan | China |
| Henan Provincial People's Hospital | Zheng'zhou | China |
| Henan Cancer Hospital | Zhengzhou | China |
| 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 |
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