NCT05134194

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

A Muti-center, Open-label, Randomized, Phase III Study of Camrelizumab Plus Treatment of Physician Choice Versus Treatment of Physician Choice for Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Systemic Chemotherapy Regimens for Advanced/Metastatic Setting

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbine	Camrelizumab in combination with capecitabine or eribulin or gemcitabine or vinorelbine
DRUG	Capecitabine/eribulin/gemcitabine/vinorelbine	Capecitabine or eribulin or gemcitabine or vinorelbine

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-01-17
• Completion: 2022-12-15
• First posted: 2021-11-24
• Last updated: 2024-04-16

Locations

1 site across 1 country: China