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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abraxane+Nedaplatin | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abraxane | Drug | Abraxane,200 mg,Via hepatic arterial catheter infusion,Every three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 33 months |
| progression-free survival, PFS |
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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.
Exclusion Criteria:
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:
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.
Current participation in another clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xaolin Li | Contact | 8615024437258 | 86057188122222 | 847678911@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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Intervention
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| Nedaplatin | Drug | Nedaplatin,100 mg,Via hepatic arterial catheter infusion,Every three weeks |
|
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
| Up to approximately 33 months |
| overall survival, OS | overall survival, OS | The time from date of enrollment to the date of death due to any cause up to approximately 33 months |
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C053989 | nedaplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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