About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients with liver metastases from breast cancer pathologically confirmed via surgery or biopsy.
Advanced breast cancer patients with imaging-confirmed visceral tumor burden solely confined to liver metastases.
Patients who have previously failed at least two lines of standard therapy (including endocrine therapy, chemotherapy, or targeted therapy), or those for whom researchers determine that local therapy would yield greater benefit.
Age 18-70 years.
Disqualifiers
History of other malignancies.
Breast and chest wall recurrence, brain metastases, multiple bone metastases with fracture risk, or visceral metastases outside the liver.
Tumor volume ≥70% of liver volume.
History of heart failure (NYHA class >I), myocardial infarction, unstable angina, stroke, or poorly controlled arrhythmia.
Trial design
Single group
Treatments tested in this trial
Abraxane
DrugAbraxane,200 mg,Via hepatic arterial catheter infusion,Every three weeks
Nedaplatin
DrugNedaplatin,100 mg,Via hepatic arterial catheter infusion,Every three weeks
Treatment groups
Trial outcomes
Primary outcomes
Liver progression-free survival, L-PFS
The period from the first liver artery chemotherapy infusion to the time of the first recorded liver tumor progression or the patient's death
Secondary outcomes
Liver objective response rate, L-ORR
The proportion of patients in the treatment group who achieved complete response (CR) or partial response (PR) for liver masses.
progression-free survival, PFS
From the time of the first hepatic artery chemotherapy infusion to the time of the first recorded local tumor progression or the patient's death
overall survival, OS
overall survival, OS
Sponsors and contacts
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