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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)

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ClinicalTrials.gov Identifier: NCT04085276
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Triple-Negative Breast Cancer Drug: JS001 Drug: Nab-Paclitaxel Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: 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)
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

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: Placebo
Placebo, i.v., q3w;

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




Primary Outcome Measures :
  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. [ Time Frame: Up to approximately 35 months from first patient in. ]
    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.

  2. PFS assessed by BICR using RECIST v1.1 in PD-L1 positive patients [ Time Frame: Up to approximately 35 months from first patient in. ]
    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 :
  1. Progression-Free Survival (PFS) assessed by investigator using RECIST v1.1. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: Up to approximately 35 months from first patient in. ]
    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator or BICR 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.

  2. Objective response rate (ORR) assessed by BICR or investigators using RECIST v1.1. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: Up to approximately 35 months from first patient in. ]
    ORR is defined as the rate of CR(Complete Response) or PR (Partial Response), as determined by BICR using RECIST v1.1

  3. Duration of response (DoR) assessed by BICR or investigators using RECIST v1.1. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: Up to approximately 35 months from first patient in. ]
    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.

  4. Disease control rate (DCR) assessed by BICR or investigators using RECIST v1.1. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: Up to approximately 35 months from first patient in. ]
    DcR is defined as the sum rate of CR, PR and SD (Stable Disease), as determined by BICR or investigators using RECIST v1.1

  5. Overall Survival (OS). Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: Up to approximately 35 months from first patient in. ]
    OS is defined as the time from randomization to death due to any cause

  6. OS rate at 12 months. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: Up to approximately 48 months from first patient in. ]
    OS is defined as the time from randomization to death due to any cause

  7. OS rate at 24 months. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: Up to approximately 48 months from first patient in. ]
    OS is defined as the time from randomization to death due to any cause

  8. OS in PD-L1 positive patients. [ Time Frame: Up to approximately 35 months from first patient in. ]
    OS is defined as the time from randomization to death due to any cause

  9. Differences in safety and tolerability as assessed by the occurrence of adverse events. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    fety is defined as risk to the subject; tolerablity is which represents the degree to which overt adverse effects can be tolerated by the subject/patient.

  10. Differences in the scores of health-related quality of life (HRQol) evaluated by EORTC QLQ-C30. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    Evaluated by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

  11. Differences in the scores of health-related quality of life (HRQol) evalued by EORTC QLQ-BR23. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    Evaluated by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR23

  12. Differences in the scores of disease/treatment-related symptoms evaluted by ECOG Performance Status. Analyzing among Intend to Treat (ITT) and PD-L1 positive patients respectively. [ Time Frame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ]
    Evaluated by Eastern Cooperative Oncogloy Group (ECOG) Performance Status



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085276


Contacts
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Contact: Zefei Jiang, prof +86(10)-66947171 jiangzefei@csco.org.cn

  Show 53 Study Locations
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.

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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT04085276     History of Changes
Other Study ID Numbers: JS001-026-III-TNBC
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action