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)

STATUS

Recruiting
End date

Dec 31, 2024
participants needed

561
sponsor

Shanghai Junshi Bioscience Co., Ltd.

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Updated on 11 October 2022

See if I qualify

paclitaxel

cancer

estrogen

measurable disease

breast cancer

growth factor

progesterone

HER2

human epidermal growth factor

triple negative breast cancer

progesterone receptor

erbb2

epidermal growth factor

taxane

triple-negative breast cancer

mammogram

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).

Details

Condition	Triple-Negative Breast Cancer
Treatment	Placebo, Nab-paclitaxel, JS001
Clinical Study Identifier	NCT04085276
Sponsor	Shanghai Junshi Bioscience Co., Ltd.
Last Modified on	11 October 2022

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Eligibility		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

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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)