HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA）for Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Detailed Description
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By enrolling patients with breast cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）for breast cancer.

Official Title
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HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA for Breast Cancer: Clinical Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: interventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:18-80 Karnofsky performance status >60 Diagnosis of breast cancer based on histology or the current accepted radiological measures. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive interventional therapy Life expectancy: Greater than 3 months Patients' routine blood test, liver function and kidney function have no obvious abnormalities Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Patients with other primary tumor except breast cancer History of coagulation disorders or anemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HepaSphere<br>breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA） | Procedure: interventional therapy<br>* breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）<br>|
| Placebo Comparator: control<br>breast cancer patients received traditional therapy | Procedure: interventional therapy<br>* breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse events |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of lesions interventional therapy that show no sign of recurrence 12 months after |  | 1 year | 
| Progress free disease (PFS) |  | 1 year | 
| Overall survival (OS) |  | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, HepaSphere