Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
NCT ID: NCT04085276
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
531 participants
INTERVENTIONAL
2018-12-21
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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JS001 Plus Nab-Paclitaxel
Patients will receive both JS001 and Nab-Paclitaxel.
JS001
JS001 240mg, i.v., q3w; Other name: Toripalimab
Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Placebo Plus Nab-Paclitaxel
Patients will receive both placebo and Nab-Paclitaxel.
Placebo
Placebo, i.v., q3w;
Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Interventions
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JS001
JS001 240mg, i.v., q3w; Other name: Toripalimab
Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Placebo
Placebo, i.v., q3w;
Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);
* Eligible for taxane monotherapy;
* No more than one line of chemotherapy in metastatic setting;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* Life expectancy of 12 weeks or more;
* At least one measurable lesion per RECIST v1.1;
* Demonstrate adequate hematologic and organ functions as defined in the protocol
Exclusion Criteria
* Prior treatment with PD-1 antibody, PD-L1 antibody, PD-L2 antibody, or CTLA4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway)
* MRI assessment during screening or previous imaging studies confirmed active or untreated brain metastases. Patients previously treated with local treatment of brain metastases has been stable for ≥ 1 month, and have stopped systemic hormonal therapy (\>10 mg/d prednisone or equivalent) \> 4 weeks before randomization can participate in the study;
* Meningeal carcinomatosis;
* Pregnancy or lactation;
* Active hepatitis B or hepatitis C.
18 Years
FEMALE
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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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
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
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 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
Countries
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Other Identifiers
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JS001-026-III-TNBC
Identifier Type: -
Identifier Source: org_study_id
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