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)

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: Completed
• Conditions: Triple-Negative Breast Cancer
• Intervention / Treatment: Drug: JS001; Drug: Nab-Paclitaxel; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 531
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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 Outcome Measures

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.	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.	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.	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)

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2018
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; 130-nm albumin-bound paclitaxel
• Other Study ID 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