drugset / Trial / NCT04085276

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

NCT04085276

Phase 3 Completed 531 enrolled Shanghai Junshi Bioscience Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2018-12-21
Primary completion
2024-12-31
Completion
2025-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Comparator Paclitaxel Small molecule 125 mg/m2 Intravenous