RecruitingPhase 2NCT07284836

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


Sponsor

Zhejiang Cancer Hospital

Enrollment

30 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a chemotherapy combination — albumin-bound paclitaxel and nedaplatin — delivered directly into the liver's blood supply (hepatic arterial infusion) for breast cancer patients whose cancer has spread to the liver and has stopped responding to standard treatments. **You may be eligible if...** - Your breast cancer has spread to the liver, confirmed by biopsy or imaging - The cancer is only in your liver (no other organ involvement) - You have already tried at least 2 standard treatments (such as hormone therapy, chemotherapy, or targeted therapy) without success - You are between 18 and 70 years old - You are able to care for yourself and perform daily activities (ECOG performance status 0–2) **You may NOT be eligible if...** - Your cancer has spread to organs other than the liver - You have not yet tried at least two prior treatments - You are older than 70 or younger than 18 - Your general health is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbraxane

Abraxane,200 mg,Via hepatic arterial catheter infusion,Every three weeks

DRUGNedaplatin

Nedaplatin,100 mg,Via hepatic arterial catheter infusion,Every three weeks


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT07284836