Hepatic arterial infusion of albumin‑bound paclitaxel plus nedaplatin for breast cancer liver metastases

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

This treatment will try giving albumin‑bound paclitaxel plus nedaplatin directly into the liver artery for people whose breast cancer has spread only to the liver after standard treatments have failed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07284836 on ClinicalTrials.gov

What this trial studies

This Phase II study gives albumin‑bound paclitaxel (Abraxane) combined with nedaplatin by hepatic arterial infusion on Day 1 of each cycle to patients with breast cancer confined to liver metastases who have failed at least two prior standard therapies. Tumor response in the liver is measured every six weeks using RECIST 1.1, with the primary outcome being liver progression‑free survival and secondary outcomes including liver objective response rate, overall progression‑free survival, and overall survival. The approach delivers higher local chemotherapy concentration to liver lesions while aiming to limit systemic exposure. Eligible patients must have adequate liver function (Child‑Pugh A–B) and ECOG performance status 0–2, and all treatment is performed at the study center.

Who should consider this trial

Good fit: Adults aged 18–70 with pathologically confirmed breast cancer limited to liver metastases who have failed at least two lines of standard therapy, have Child‑Pugh A–B liver function, and ECOG 0–2 are the intended participants.

Not a fit: Patients with significant extrahepatic metastases, poor liver function (Child‑Pugh C), or who cannot undergo hepatic arterial infusion are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could improve control of liver tumors and extend the time patients remain free of liver progression after standard treatments have failed.

How similar studies have performed: Hepatic arterial infusion has shown activity for liver‑dominant metastases in other cancers and small breast cancer series have reported responses, but high‑quality randomized evidence in this exact regimen is limited.

Eligibility criteria

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.

Exclusion Criteria:

1. History of other malignancies.
2. Breast and chest wall recurrence, brain metastases, multiple bone metastases with fracture risk, or visceral metastases outside the liver.
3. Tumor volume ≥70% of liver volume.
4. History of heart failure (NYHA class \>I), myocardial infarction, unstable angina, stroke, or poorly controlled arrhythmia.
5. Active infection, severe allergic reactions, or autoimmune diseases, including but not limited to:

   * Active tuberculosis (TB), currently receiving or having received anti-TB treatment within the past year;
   * HIV infection (HIV1/2 antibody positive);
   * Active hepatitis B or hepatitis C virus infection;
   * History of systemic lupus erythematosus, rheumatoid arthritis, chronic lymphocytic thyroiditis, hyperthyroidism, polyarteritis nodosa, autoimmune hemolytic anemia, etc.
6. Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period.
7. Uncontrolled hypertension, diabetes, or other serious diseases.
8. Severe uncontrolled dysfunction of the liver, kidneys, lungs, or other vital organs.
9. Pregnant or lactating patients.
10. History of mental illness.
11. Known allergy to albumin-bound paclitaxel, nedaplatin, or related drugs.
12. Current participation in another clinical trial.

Where this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Xaolin Li

Conditions Hepatic Artery Infusion; Liver Metastasis of Breast Cancer