Surufatinib Combined With Tislelizumab in the Second-line and Further Treatment of Triple-negative Breast Cancer
NCT05746728 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2023-04-06
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
- 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
Sponsors & Collaborators
-
Huihua Xiong
lead OTHER
Principal Investigators
-
Huihua Xiong · Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-30
- Primary Completion
- 2024-08-31
- Completion
- 2025-08-31
Countries
- China
Study Locations
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