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

Primary Purpose

Triple-Negative Breast Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
JS001
Nab-Paclitaxel
Placebo
Nab-Paclitaxel
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-Negative Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Fifth Medical Center of PLA General Hospital
  • Beijing Hospital
  • Chinese PLA General Hospital
  • Peking University Shougang Hospital
  • Affiliated Hospital of Hebei University
  • The first affiliated Hospital of Bengbu Medical College
  • Jilin Cancer Hospital
  • The First Hospital of Jilin University
  • Hunan Cancer Hospital
  • Affiliated Hospital of Chengde Medical University
  • Sichuan Cancer Hospital
  • Chongqing Cancer Hospital
  • The Second Hospital of Dalian Medical University
  • The First People's Hospital of Foshan
  • Fujian Medical University Union Hospital
  • Guangdong General Hospital
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • Sun Yat-sen University Cancer Center
  • The First Affiliated Hospital, Sun Yat-sen University
  • The Women and Children's Hospital of Guangdong Province
  • The First Affiliated Hospital Zhejiang University
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Zhejiang Cancer Hospital
  • Harbin Medical University Cancer Hospital
  • Anhui Province Hospital & The First Affiliated Hospital of USTC
  • The First Affiliated Hospital of Anhui Medical University
  • The Second Hospital of Anhui Medical University
  • Shandong Cancer Hospital
  • Yunnan Cancer Hospital
  • Linyi Cancer Hospital
  • The Affiliated Hospita of of Southwest Medical University
  • Jiangxi Cancer Hospital
  • The Third Hospital of Nanchang
  • Jiangsu Cancer Hospital
  • Jiangsu Province Hospital
  • The Affiliated Hospital of Qingdao University
  • Changhai Hospital
  • Shanghai General Hospital
  • Liaoning Cancer Hospital&Intitute
  • The First Hospital of China Medical University
  • The Fourth Hospital of Hebei Medical University
  • Cancer Hospital Affiliated to Xinjiang Medical University
  • Hubei Cancer Hospital
  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Affiliated Hospital of Jiangnan University（Wuxi NO.4 People's Hospital）
  • The First Affiliated Hospital of Xiamen University
  • Xiangyang Central Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The Second Affiliated Hospital of The PLA Air Force Military Medical University
  • General Hospital of Ningxia Medical University
  • Henan Provincial People's Hospital
  • Henan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JS001 Plus Nab-Paclitaxel

Placebo Plus Nab-Paclitaxel

Arm Description

Patients will receive both JS001 and Nab-Paclitaxel.

Patients will receive both placebo and Nab-Paclitaxel.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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.
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
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
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.
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
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）
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

Full Information

First Posted
July 25, 2019
Last Updated
March 5, 2023
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04085276
Brief Title
Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
Acronym
TORCHLIGHT
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-Negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
531 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JS001 Plus Nab-Paclitaxel
Arm Type
Experimental
Arm Description
Patients will receive both JS001 and Nab-Paclitaxel.
Arm Title
Placebo Plus Nab-Paclitaxel
Arm Type
Placebo Comparator
Arm Description
Patients will receive both placebo and Nab-Paclitaxel.
Intervention Type
Drug
Intervention Name(s)
JS001
Intervention Description
JS001 240mg, i.v., q3w; Other name: Toripalimab
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Intervention Description
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, i.v., q3w;
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Intervention Description
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Up to approximately 61 months from first patient in.
Title
PFS assessed by BICR using RECIST v1.1 in PD-L1 positive patients
Description
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.
Time Frame
Up to approximately 61 months from first patient in.
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS) assessed by investigator using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
Description
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.
Time Frame
Up to approximately 61 months from first patient in.
Title
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.
Description
ORR is defined as the rate of CR(Complete Response) or PR (Partial Response), as determined by BICR using RECIST v1.1
Time Frame
Up to approximately 61 months from first patient in.
Title
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.
Description
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.
Time Frame
Up to approximately 61 months from first patient in.
Title
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.
Description
DCR is defined as the sum rate of CR, PR and SD (Stable Disease), as determined by BICR or investigators using RECIST v1.1
Time Frame
Up to approximately 61 months from first patient in.
Title
Overall Survival (OS). Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
Description
OS is defined as the time from randomization to death from any cause
Time Frame
Up to approximately 61 months from first patient in.
Title
OS rate at 12 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
Up to approximately 61 months from first patient in.
Title
OS rate at 24 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
Description
OS is defined as the time from randomization to death from any cause
Time Frame
Up to approximately 61 months from first patient in.
Title
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.
Description
From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months）
Time Frame
From Day 1 to death from any cause, assessed up to end of study (up to approximately 46 months）
Title
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.
Description
Evaluated by Eastern Cooperative Oncogloy Group (ECOG) Performance Status
Time Frame
From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Fifth Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Shougang Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
Country
China
Facility Name
The first affiliated Hospital of Bengbu Medical College
City
Bengbu
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Facility Name
Affiliated Hospital of Chengde Medical University
City
Chengde
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
Country
China
Facility Name
The First People's Hospital of Foshan
City
Foshan
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
Country
China
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
Facility Name
The Women and Children's Hospital of Guangdong Province
City
Guangzhou
Country
China
Facility Name
The First Affiliated Hospital Zhejiang University
City
Hangzhou
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
Country
China
Facility Name
Anhui Province Hospital & The First Affiliated Hospital of USTC
City
Hefei
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Facility Name
Linyi Cancer Hospital
City
Linyi
Country
China
Facility Name
The Affiliated Hospita of of Southwest Medical University
City
Luzhou
Country
China
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
Country
China
Facility Name
The Third Hospital of Nanchang
City
Nanchang
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
Facility Name
Liaoning Cancer Hospital&Intitute
City
Shenyang
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
Country
China
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Facility Name
Cancer Hospital Affiliated to Xinjiang Medical University
City
Urumqi
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
Country
China
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Affiliated Hospital of Jiangnan University（Wuxi NO.4 People's Hospital）
City
Wuxi
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Xiangyang Central Hospital
City
Xiangyang
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xian
Country
China
Facility Name
The Second Affiliated Hospital of The PLA Air Force Military Medical University
City
Xian
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zheng'zhou
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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