NCT05746728

Surufatinib Combined With Tislelizumab in the Second-line and Further Treatment of Triple-negative Breast Cancer

A Multicenter, Open-label, Single-arm Study of Surufatinib in Combination With Tislelizumab for Second-line and Further Treatment of Metastatic Triple-negative Breast Cancer (TNBC)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Huihua Xiong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, single-arm clinical study designed to evaluate the safety and efficacy of surufatinib combined with tislelizumab in the treatment of metastatic triple-negative breast cancer (TNBC). The study will be conducted in two parts; Safety lead-in phase and dose expansion phase.

Conditions

• Metastatic Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib	Safety run-in phase: 200-250mg, QD, Q3W Dose expansion phase: according to the dose determined in the safety run-in phase
DRUG	Tislelizumab	200mg, d1, iv, Q3W

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2023-02-28
• Last updated: 2023-04-06

Locations

1 site across 1 country: China