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

NCT07284836 | Recruiting Phase 2

• 1 other identifier: IIT-2024-467
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Artery Infusion; Liver Metastasis of Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Up to approximately 33 months

Secondary Outcomes (3)

• Liver objective response rate, L-ORR

  Up to approximately 33 months

• progression-free survival, PFS

  Up to approximately 33 months

• overall survival, OS

  The time from date of enrollment to the date of death due to any cause up to approximately 33 months

Study Arms (1)

Abraxane+Nedaplatin

EXPERIMENTAL

1. Abraxane：Dosage: 200 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes 2. Nedaplatin：Dosage: 100 mg，Route of Administration: Via hepatic arterial catheter infusion，Frequency: Every three weeks，Infusion Duration: Approximately 30 minutes，Treatment Cycle: Each cycle spans 3 weeks, for a total of 6-8 cycles. The exact number of cycles may be adjusted based on the patient's tolerance and disease response.

Drug: Abraxane; Drug: Nedaplatin

Interventions

Abraxane DRUG

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

Abraxane+Nedaplatin

Nedaplatin DRUG

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

Abraxane+Nedaplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;

You may not qualify if:

• 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.
• 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.
• Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period.
• Uncontrolled hypertension, diabetes, or other serious diseases.
• Severe uncontrolled dysfunction of the liver, kidneys, lungs, or other vital organs.
• Pregnant or lactating patients.
• History of mental illness.
• Known allergy to albumin-bound paclitaxel, nedaplatin, or related drugs.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Albumin-Bound Paclitaxel; nedaplatin

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Xaolin Li

CONTACT

8615024437258; 847678911@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Intervention

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)