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

Inclusion Criteria

• •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.
• •* ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2. • 0: Fully active, without any restrictions; • 1: Restricted in physically strenuous activity but ambulatory and able to carry out light work; • 2: Ambulatory and capable of all self-care but unable to carry out any work activities.
• •* Liver function score (e.g., Child-Pugh) Class A-B.
• •• Class A (5-6 points): Good hepatic reserve, well tolerated to surgery, low incidence of postoperative complications and mortality;
• •• Class B (7-9 points): Moderately impaired hepatic reserve, poorly tolerated to surgery, increased postoperative complications and mortality;
• •• Class C (≥10 points): Severely impaired hepatic reserve, very poorly tolerated to surgery, high risk of postoperative complications and mortality; surgery is generally not recommended.
• •⑦ Adequate organ function.
• •• Hemoglobin ≥90 g/L, white blood cells ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L;
• •• Serum creatinine ≤1.0×upper normal limit (UNL), and creatinine clearance \>60 mL/min;
• •• Alanine aminotransferase (ALT) ≤1.5×UNL, aspartate aminotransferase (AST) ≤1.5×UNL, alkaline phosphatase (ALP) ≤1.5×UNL;
• •• Total bilirubin (TBIL) ≤1.5×UNL;
• •• No severe abnormalities on electrocardiogram, left ventricular ejection fraction (LVEF) ≥50%;
• •• Absence of other severe medical conditions or comorbidities that would preclude tolerance to the clinical trial intervention.
• •* Signed informed consent, indicating understanding of the trial's purpose, risks, and potential benefits.