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Completed

NCT Number: NCT04085276

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

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).

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Key information

Conditions

Triple-negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JS001

Drug

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

Nab-paclitaxel

Drug

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

Placebo

Drug

Placebo, i.v., q3w;

Primary outcomes

  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 61 months from first patient in.

    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.

  2. PFS assessed by BICR using RECIST v1.1 in PD-L1 positive patients

    Time frame: Up to approximately 61 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 outcomes

  1. Progression-Free Survival (PFS) assessed by investigator using RECIST v1.1. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.

    Time frame: Up to approximately 61 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 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.

  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.

    Time frame: Up to approximately 61 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 PD-L1 positive patients and Intend to Treat (ITT) respectively.

    Time frame: Up to approximately 61 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 PD-L1 positive patients and Intend to Treat (ITT) respectively.

    Time frame: Up to approximately 61 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 PD-L1 positive patients and Intend to Treat (ITT) respectively.

    Time frame: Up to approximately 61 months from first patient in.

    OS is defined as the time from randomization to death from any cause

  6. OS rate at 12 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.

    Time frame: Up to approximately 61 months from first patient in.

    OS is defined as the time from randomization to death from any cause.

  7. OS rate at 24 months. Analyzing among PD-L1 positive patients and Intend to Treat (ITT) respectively.

    Time frame: Up to approximately 61 months from first patient in.

    OS is defined as the time from randomization to death from any cause

  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.

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

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

  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.

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

    Evaluated by Eastern Cooperative Oncogloy Group (ECOG) Performance Status

  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.

    Time frame: Up to approximately 61 months from first patient in.

    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.

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study 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)

Acronym: TORCHLIGHT

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Sep 11, 2019
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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