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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorZhejiang Cancer Hospital

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

Qualifiers

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

Treatments tested in this trial

  • Abraxane
  • Nedaplatin

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators