drugset / Trial / NCT04335006

A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.

NCT04335006

Phase 3 Terminated 80 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).

Timeline

Start
2020-07-14
Primary completion
2023-04-14
Completion
2023-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Carelizumab Unknown Intravenous
Subject Paclitaxel Small molecule Intravenous
Subject Rivoceranib Small molecule Oral