NCT06308939

Eribulin Combined With Sintilimab as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer:A Multicenter, Single-arm,Phase II Clinical Trial

Explore the Efficacy and Safety of Eribulin Combined With Sintilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic HER2-negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Eribulin combined with Sintilimab in the first-line treatment of unresectable locally advanced or metastatic HER2-negative breast cancer.

Detailed description

Eribulin: According to the standard dose,1.4mg/m\^2 day1、8，repeated every 3 week. After 6 cycles, the investigator decided whether to continue treatment depending on the patient's tolerance. Sintilimab: 500mg once every three weeks. The patients were treated until disease progression or intolerable side effects.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin	1.4mg/m\^2 day1、8，repeated every 3 week.
DRUG	Sintilimab	500mg once every three weeks.

Timeline

• Start date: 2024-03-08
• Primary completion: 2025-12-31
• Completion: 2026-08-31
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: China