A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC

Summary

This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

Timeline

Start

2018-12-21

Primary completion

2019-12-30

Completion

2020-07-30

Publications

• Jiang Z, Ouyang Q, Sun T, Zhang Q, Teng Y, Cui J, Wang H, Yin Y, Wang X, Zhou X, Wang Y, Sun G, Wang J, Zhang L, Yang J, Qian J, Yan M, Liu X, Yi T, Cheng Y, Li M, Zang A, Wang S, Wang C, Wu X, Cheng J, Li H, Lin Y, Geng C, Gu K, Xie C, Xiong H, Wu X, Yang J, Li Q, Chen Y, Li F, Zhang A, Zhang Y, Wu Y, Nie J, Liu Q, Wang K, Mo X, Chen L, Pan Y, Fu P, Zhang H, Pang D, Sheng Y, Han Y, Wang H, Cang S, Luo X, Yu W, Deng R, Yang C, Keegan P. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2024 Jan;30(1):249-256. doi: 10.1038/s41591-023-02677-x. Epub 2024 Jan 8.

Drugs

Indications