Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
TORCHLIGHT
A Randomized, Double-Blind, Multicenter, Phase III Study of Toripalimab(JS001) in Combination With Nab-Paclitaxel Versus Placebo Plus Nab-Paclitaxel for Patients With Metastatic or Recurrent Triple-Negative Breast Cancer With or Without Systemic Treatment (TORCHLIGHT)
1 other identifier
interventional
531
1 country
55
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2018
Longer than P75 for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 21, 2018
CompletedFirst Submitted
Initial submission to the registry
July 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedApril 16, 2026
April 1, 2026
6 years
July 25, 2019
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Secondary Outcomes (10)
Progression-Free Survival (PFS) assessed by investigator using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
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.
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.
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.
Up to approximately 61 months from first patient in.
Overall Survival (OS). Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
Up to approximately 61 months from first patient in.
- +5 more secondary outcomes
Study Arms (2)
JS001 Plus Nab-Paclitaxel
EXPERIMENTALPatients will receive both JS001 and Nab-Paclitaxel.
Placebo Plus Nab-Paclitaxel
PLACEBO COMPARATORPatients will receive both placebo and Nab-Paclitaxel.
Interventions
Eligibility Criteria
You may qualify if:
- Metastatic or recurrent triple negative breast cancer (TNBC);
- 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
You may not qualify if:
- Prior treatment with taxane as first line treatment;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071, 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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2019
First Posted
September 11, 2019
Study Start
December 21, 2018
Primary Completion
December 31, 2024
Study Completion
February 28, 2025
Last Updated
April 16, 2026
Record last verified: 2026-04