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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Abraxane

    Drug

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

  • Nedaplatin

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Abraxane+NedaplatinExperimental treatment 2 interventions

Trial outcomes

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

Time frame
Up to approximately 33 months

Secondary outcomes

1

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.

Time frame
Up to approximately 33 months
2

progression-free survival, PFS

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

Time frame
Up to approximately 33 months
3

overall survival, OS

overall survival, OS

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

Other outcomes

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