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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523417
• Other study ID #: Breast Cancer HepaSphere
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 12, 2015
• Last updated: February 23, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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: ?,?,?

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Central laboratory in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

References & Publications (1)

Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse events		1 year	Yes
Secondary	Percentage of lesions interventional therapy that show no sign of recurrence 12 months after		1 year	No
Secondary	Progress free disease (PFS)		1 year	No
Secondary	Overall survival (OS)		3 year	No

External Links

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