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

Triple-Negative Breast Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04085276
• Other study ID #: JS001-026-III-TNBC
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 21, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 531
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer

Intervention

Drug:
• JS001
JS001 240mg, i.v., q3w; Other name: Toripalimab
• Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
• Placebo
Placebo, i.v., q3w;
• Nab-Paclitaxel
Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding
China	Beijing Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing
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	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 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	Urumqi
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 Xiamen University	Xiamen
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xian
China	The Second Affiliated Hospital of The PLA Air Force Military Medical University	Xian
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

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)
Secondary	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)