NCT06202313

Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer

A Multicenter, Randomized, Controlled, Open Label Clinical Study on the Treatment of Recurrent or Metastatic Triple Negative Breast Cancer With Cadonilimab Combined With Eribulin Versus Eribulin Alone

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) plus Eribulin compared to the efficacy and safety of Eribulin monotherapy in the treatment of adult patients with recurrent, or metastatic triple negative breast cancer. The primary study hypothes is that the combination of Cadonilimab (AK104) plus Eribulin is superior to Eribulin monotherapy with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Cadonilimab	Participants receive Cadonilimab 10mg/kg IV on Day 1 of each 21-day cycle PLUS Eribulin 1.4mg/m\^2 IV on Days 1 and 8 of each 21-day cycle.
DRUG	Eribulin	Participants receive Eribulin 1.4mg/m\^2 IV on Days 1 and 8 of each 21-day cycle.

Timeline

• Start date: 2024-02-10
• Primary completion: 2025-12-30
• Completion: 2028-12-30
• First posted: 2024-01-11
• Last updated: 2024-01-11

Locations

1 site across 1 country: China