- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02523417
HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA)for Breast Cancer
February 23, 2016 updated by: Fuda Cancer Hospital, Guangzhou
HepaSphere Interventional Therapy Using Digital Subtraction Angiography(DSA for Breast Cancer: Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography(DSA)for breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Central laboratory in Fuda cancer hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HepaSphere
breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
|
breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
|
Placebo Comparator: control
breast cancer patients received traditional therapy
|
breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography(DSA)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Adverse events
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progress free disease (PFS)
Time Frame: 1 year
|
1 year
|
Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
Time Frame: 1 year
|
1 year
|
Overall survival (OS)
Time Frame: 3 year
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
August 12, 2015
First Submitted That Met QC Criteria
August 13, 2015
First Posted (Estimate)
August 14, 2015
Study Record Updates
Last Update Posted (Estimate)
February 25, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breast Cancer HepaSphere
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on interventional therapy
-
Fuda Cancer Hospital, GuangzhouCompleted
-
Fuda Cancer Hospital, GuangzhouWithdrawn
-
Fuda Cancer Hospital, GuangzhouCompletedCervical CarcinomaChina
-
Fuda Cancer Hospital, GuangzhouCompletedNasopharyngeal CarcinomaChina
-
Fuda Cancer Hospital, GuangzhouNo longer available
-
US Department of Veterans AffairsCompleted
-
Columbia UniversityNational Institute of Neurological Disorders and Stroke (NINDS)CompletedArteriovenous Malformations, CerebralUnited States, Brazil, Canada, Australia, Austria, Finland, France, Germany, Italy, Korea, Republic of, Netherlands, Spain, Switzerland, United Kingdom
-
Sun Yat-sen UniversityThird Affiliated Hospital, Sun Yat-Sen UniversityUnknown
-
Fuda Cancer Hospital, GuangzhouCompleted
-
University Hospital, CaenActive, not recruitingAnorexia Nervosa | Videoconferencing | Exercise TherapyFrance