NCT07284836

Phase II Trial of Albumin-Bound Paclitaxel Combined With Nedaplatin (TP) Via Hepatic Arterial Infusion for Advanced Breast Cancer Patients With Liver Metastases After Failure of Standard Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Study Objective: To Evaluate the Efficacy of Albumin-Bound Paclitaxel Combined with Nedaplatin via Hepatic Arterial Infusion as Later-Line Therapy for Breast Cancer Patients with Liver Metastases After Failure of Standard Treatment. Outcome Measures：Primary Outcome: Liver Progression-Free Survival (LPFS) Secondary Outcomes:Liver Objective Response Rate (LORR)、Progression-Free Survival (PFS) and Overall Survival (OS) Participants will: * Albumin-bound paclitaxel + nedaplatin (TP) regimen is administered via hepatic arterial infusion chemotherapy on Day 1 of each cycle. * Tumor response will be assessed every 6 weeks (±7 days) according to RECIST 1.1 criteria until disease progression is determined by the investigator.

Conditions

• Hepatic Artery Infusion
• Liver Metastasis of Breast Cancer

Interventions

Type	Name	Description
DRUG	Abraxane	Abraxane，200 mg，Via hepatic arterial catheter infusion，Every three weeks
DRUG	Nedaplatin	Nedaplatin，100 mg，Via hepatic arterial catheter infusion，Every three weeks

Timeline

• Start date: 2025-02-01
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: China