Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment (TORCHLIGHT)

April 13, 2026 updated by: Shanghai Junshi Bioscience Co., Ltd.

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
531

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Baoding, China
        • Affiliated Hospital of Hebei University
      • Bengbu, China
        • The First Affiliated Hospital of Bengbu Medical College
      • Changchun, China
        • Jilin Cancer Hospital
      • Changchun, China
        • The First Hospital of Jilin University
      • Changsha, China
        • Hunan Cancer Hospital
      • Chengde, China
        • Affiliated Hospital of Chengde Medical University
      • Chengdu, China
        • Sichuan Cancer Hospital
      • Chongqing, China
        • Chongqing Cancer Hospital
      • Dalian, China
        • The Second Hospital of Dalian Medical University
      • Foshan, China
        • The First People's Hospital of Foshan
      • Fuzhou, China
        • Fujian Medical University Union Hospital
      • Guangzhou, China
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Guangzhou, China
        • Sun Yat-sen University Cancer Center
      • Guangzhou, China
        • Guangdong General Hospital
      • Guangzhou, China
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, China
        • The Women and Children's Hospital of Guangdong Province
      • Hangzhou, China
        • Zhejiang Cancer Hospital
      • Hangzhou, China
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, China
        • The First Affiliated Hospital Zhejiang University
      • Harbin, China
        • Harbin medical university cancer hospital
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, China
        • The second hospital of Anhui medical university
      • Hefei, China
        • Anhui Province Hospital & The First Affiliated Hospital of USTC
      • Hohhot, China
        • The Affiliated Hospita of Inner Mongolia Medical University
      • Jinan, China
        • Shandong Cancer Hospital
      • Kunming, China
        • Yunnan Cancer Hospital
      • Linyi, China
        • Linyi Cancer Hospital
      • Luzhou, China
        • The Affiliated Hospita of of Southwest Medical University
      • Nanchang, China
        • The First Affiliated Hospital of NanChang University
      • Nanchang, China
        • Jiangxi Cancer Hospital
      • Nanchang, China
        • The Third Hospital of Nanchang
      • Nanjing, China
        • Jiangsu Province Hospital
      • Nanjing, China
        • Jiangsu Cancer Hospital
      • Qingdao, China
        • The Affiliated Hospital of Qingdao University
      • Shanghai, China
        • Shanghai General Hospital
      • Shanghai, China
        • Changhai Hospital
      • Shenyang, China
        • The First Hospital of China Medical University
      • Shenyang, China
        • Liaoning Cancer Hospital&Intitute
      • Shijiazhuang, China
        • The Fourth Hospital of Hebei Medical University
      • Wuhan, China
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, China
        • Hubei Cancer Hospital
      • Wuhan, China
        • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuxi, China
        • Affiliated Hospital of Jiangnan University（Wuxi NO.4 People's Hospital）
      • Xi'an, 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
      • Xiamen, China
        • The first affiliated hospital of xiamen university
      • Xiangyang, China
        • Xiangyang Central Hospital
      • Yinchuan, China
        • General Hospital of Ningxia Medical University
      • Zheng'zhou, China
        • Henan Provincial People's Hospital
      • Zhengzhou, China
        • Henan Cancer Hospital
      • Ürümqi, China
        • Cancer Hospital affiliated to Xinjiang Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Chinese PLA General Hospital
      • Beijing, Beijing Municipality, China
        • Beijing Hospital
      • Beijing, Beijing Municipality, China, 100071
        • The Fifth Medical Center of PLA General Hospital
      • Beijing, Beijing Municipality, China
        • Peking University Shougang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JS001 Plus Nab-Paclitaxel
Patients will receive both JS001 and Nab-Paclitaxel.
Drug: JS001
JS001 240mg, i.v., q3w; Other name: Toripalimab
Drug: Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Placebo Comparator: Placebo Plus Nab-Paclitaxel
Patients will receive both placebo and Nab-Paclitaxel.
Drug: Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Drug: Placebo
Placebo, i.v., q3w;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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.
Time Frame: Up to approximately 61 months from first patient in.
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
Time Frame: Up to approximately 61 months from first patient in.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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.
Time Frame: Up to approximately 61 months from first patient in.
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.
Progression-Free Survival (PFS) assessed by investigator using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
Time Frame: Up to approximately 61 months from first patient in.
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.
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.
Time Frame: Up to approximately 61 months from first patient in.
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.
Time Frame: Up to approximately 61 months from first patient in.
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.
Time Frame: Up to approximately 61 months from first patient in.
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.
Time Frame: Up to approximately 61 months from first patient in.
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.
Time Frame: Up to approximately 61 months from first patient in.
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.
Time Frame: Up to approximately 61 months from first patient in.
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.
Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 46 months）
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.
Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Junshi Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JS001-026-III-TNBC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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