NCT06910072

Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. The main endpoint of the study is pCR, 32 patients are scheduled to be enrolled.

Conditions

• Triple-Negative Breast Cancer (TNBC)
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab	paclitaxel polymeric micelles 300mg/m2, d1 carboplatin AUC=5, d1 iparomilimab and tuvonralimab 5mg/kg, d1 Every 3 weeks (Q3W) is a cycle, a total of 6 cycles.

Timeline

• Start date: 2025-04-02
• Primary completion: 2026-10-01
• Completion: 2028-10-01
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: China