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

Fuda Cancer Hospital, Guangzhou15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

interventional therapyPROCEDURE

breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age:18-80 2. Karnofsky performance status \>60 3. Diagnosis of breast cancer based on histology or the current accepted radiological measures. 4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ 5. Will receive interventional therapy 6. Life expectancy: Greater than 3 months 7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities 8. Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: 1. Patients with other primary tumor except breast cancer 2. History of coagulation disorders or anemia

Locations (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Number of participants with Adverse events

Time frame: 1 year

Secondary Outcomes

Percentage of lesions interventional therapy that show no sign of recurrence 12 months after

Time frame: 1 year

Progress free disease (PFS)

Time frame: 1 year

Overall survival (OS)

Time frame: 3 year

Data from ClinicalTrials.gov

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