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Triple-Negative Breast CancerPhase 3TORCHLIGHTNCT04085276

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

A Phase 3 study testing JS001 and Nab-Paclitaxel in people with Triple-Negative Breast Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 55 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple-Negative Breast Cancer
What is being tested?
JS001 and Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
531 participants
Where
55 sitesChina
Study dates
21 Dec 2018to 28 Feb 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

China55 sites

  • Affiliated Hospital of Hebei University

    Baoding

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100071

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality

  • The first affiliated Hospital of Bengbu Medical College

    Bengbu

  • Jilin Cancer Hospital

    Changchun

  • The First Hospital of Jilin University

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • Affiliated Hospital of Chengde Medical University

    Chengde

  • Sichuan Cancer Hospital

    Chengdu

  • Chongqing Cancer Hospital

    Chongqing

  • The Second Hospital of Dalian Medical University

    Dalian

  • The First People's Hospital of Foshan

    Foshan

  • Fujian Medical University Union Hospital

    Fuzhou

  • Guangdong General Hospital

    Guangzhou

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

  • Sun Yat-sen University Cancer Center

    Guangzhou

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou

  • The Women and Children's Hospital of Guangdong Province

    Guangzhou

  • The First Affiliated Hospital Zhejiang University

    Hangzhou

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Anhui Province Hospital & The First Affiliated Hospital of USTC

    Hefei

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • The Second Hospital of Anhui Medical University

    Hefei

  • The Affiliated Hospita of Inner Mongolia Medical University

    Hohhot

  • Shandong Cancer Hospital

    Jinan

  • Yunnan Cancer Hospital

    Kunming

  • Linyi Cancer Hospital

    Linyi

  • The Affiliated Hospita of of Southwest Medical University

    Luzhou

  • Jiangxi Cancer Hospital

    Nanchang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • The Third Hospital of Nanchang

    Nanchang

  • Jiangsu Cancer Hospital

    Nanjing

  • Jiangsu Province Hospital

    Nanjing

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • Changhai Hospital

    Shanghai

  • Shanghai General Hospital

    Shanghai

  • Liaoning Cancer Hospital&Intitute

    Shenyang

  • The First Hospital of China Medical University

    Shenyang

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi

  • Hubei Cancer Hospital

    Wuhan

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • Affiliated Hospital of Jiangnan University（Wuxi NO.4 People's Hospital）

    Wuxi

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of The PLA Air Force Military Medical University

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Xiangyang Central Hospital

    Xiangyang

  • General Hospital of Ningxia Medical University

    Yinchuan

  • Henan Provincial People's Hospital

    Zheng'zhou

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

About this study

Official title: 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).

Being tested
JS001, Nab-Paclitaxel, Placebo
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS001Drug

    JS001 240mg, i.v., q3w; Other name: Toripalimab

  • Nab-PaclitaxelDrug

    Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w

  • PlaceboDrug

    Placebo, i.v., q3w;

  • Nab-PaclitaxelDrug

    Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w

Study groups in NCT04085276
Study groupRoleWhat they receive
JS001 Plus Nab-PaclitaxelExperimentalPatients will receive both JS001 and Nab-Paclitaxel.
Receives: Drug: JS001; Drug: Nab-Paclitaxel
Placebo Plus Nab-PaclitaxelPlacebo comparatorPatients will receive both placebo and Nab-Paclitaxel.
Receives: Drug: Placebo; Drug: Nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 61 months from first patient in.

  2. 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.

    Measured: Up to approximately 61 months from first patient in.

Secondary outcomes (10)

  1. 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.

    Measured: Up to approximately 61 months from first patient in.

  2. 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

    Measured: Up to approximately 61 months from first patient in.

  3. 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.

    Measured: Up to approximately 61 months from first patient in.

  4. 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

    Measured: Up to approximately 61 months from first patient in.

  5. 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

    Measured: Up to approximately 61 months from first patient in.

  6. 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.

    Measured: Up to approximately 61 months from first patient in.

  7. 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

    Measured: Up to approximately 61 months from first patient in.

  8. 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）

    Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 46 months）

  9. 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

    Measured: From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months)

  10. 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.

    Measured: Up to approximately 61 months from first patient in.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2019
  2. Study start21 Dec 2018
  3. Primary completion31 Dec 2024
  4. Study completion28 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
531 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04085276
Sponsor's protocol ID
JS001-026-III-TNBC
Acronym
TORCHLIGHT
Status last verified
Apr 2026
First submitted
25 Jul 2019
Last updated
16 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JS001 and Nab-Paclitaxel in people with Triple-Negative Breast Cancer, run by Shanghai Junshi Bioscience Co., Ltd. at 55 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04085276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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