Clinical trial NCT04085276: Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Triple-Negative Breast Cancer
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 531
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
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.
timeFrame: Up to approximately 61 months from first patient in.
measure: PFS assessed by BICR using RECIST v1.1 in PD-L1 positive patients
timeFrame: Up to approximately 61 months from first patient in.
Secondary outcomes:
measure: Progression-Free Survival (PFS) assessed by investigator using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
timeFrame: Up to approximately 61 months from first patient in.
measure: 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.
timeFrame: Up to approximately 61 months from first patient in.
measure: 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.
timeFrame: Up to approximately 61 months from first patient in.
measure: 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.
timeFrame: Up to approximately 61 months from first patient in.
measure: Overall Survival (OS). Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
timeFrame: Up to approximately 61 months from first patient in.
measure: OS rate at 12 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
timeFrame: Up to approximately 61 months from first patient in.
measure: OS rate at 24 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.
timeFrame: Up to approximately 61 months from first patient in.
measure: 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.
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 46 months）
measure: 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.
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 61months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
city: Bengbu
country: China
facility: The first affiliated Hospital of Bengbu Medical College
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: Hunan Cancer Hospital
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
city: Foshan
country: China
facility: The First People's Hospital of Foshan
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: The Women and Children's Hospital of Guangdong Province
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Hefei
country: China
facility: Anhui Province Hospital & The First Affiliated Hospital of USTC
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Linyi
country: China
facility: Linyi Cancer Hospital
city: Luzhou
country: China
facility: The Affiliated Hospita of of Southwest Medical University
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
city: Nanchang
country: China
facility: The Third Hospital of Nanchang
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital&Intitute
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
city: Urumqi
country: China
facility: Cancer Hospital Affiliated to Xinjiang Medical University
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University（Wuxi NO.4 People's Hospital）
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Xian
country: China
facility: The Second Affiliated Hospital of The PLA Air Force Military Medical University
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Zheng'zhou
country: China
facility: Henan Provincial People's Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
References: