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Completed

NCT Number: NCT02523417

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interventional therapy

Procedure

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

Primary outcomes

  1. Number of participants with Adverse events

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

  2. Progress free disease (PFS)

    Time frame: 1 year

  3. Overall survival (OS)

    Time frame: 3 year

Sponsors and collaborators

Lead sponsor

Fuda Cancer Hospital, Guangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Feb 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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