Overview

A Study of Camrelizumab in Combination With Chemotherapy Regimen Comparative Chemotherapy Regimen for Metastatic Triple-negative Breast Cancer

Status:
Not yet recruiting

Trial end date:
2023-04-30

Target enrollment:

Participant gender:

Summary

Approximately 104 subjects with recurrent or metastatic IM triple negative breast cancer were planned to be included in the study, and screened eligible subjects were randomly assigned in a 1:1 ratio to treatment with the combination of Camrelizumab and investigator's choice of chemotherapy (test arm), treatment with investigator's choice of chemotherapy (control arm), and the stratification factor was liver metastasis (with vs without). After enrollment, subjects in the test group were treated with Camrelizumab 200 mg IV every 3 weeks for one cycle. The investigator's choice of single agent chemotherapy regimen (capecitabine, eribulin, gemcitabine, or vinorelbine) was every 3 weeks for one cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation at the investigator's discretion.

Phase:

Phase 3

Details

Lead Sponsor:

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Treatments:

Capecitabine
Gemcitabine
Vinorelbine