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) (TORCHLIGHT)

  • End date
    Dec 31, 2024
  • participants needed
  • sponsor
    Shanghai Junshi Bioscience Co., Ltd.
Updated on 11 October 2022
measurable disease
breast cancer
growth factor
human epidermal growth factor
triple negative breast cancer
progesterone receptor
epidermal growth factor
triple-negative breast cancer


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 Triple-Negative Breast Cancer
Treatment Placebo, Nab-paclitaxel, JS001
Clinical Study IdentifierNCT04085276
SponsorShanghai Junshi Bioscience Co., Ltd.
Last Modified on11 October 2022


Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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