NCT04085276

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 531 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	JS001	JS001 240mg, i.v., q3w; Other name: Toripalimab
DRUG	Nab-Paclitaxel	Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
DRUG	Placebo	Placebo, i.v., q3w;
DRUG	Nab-Paclitaxel	Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w

Timeline

• Start date: 2018-12-21
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2019-09-11
• Last updated: 2026-04-16

Locations

55 sites across 1 country: China