UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009090
Receipt No. R000010665
Scientific Title Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)
Date of disclosure of the study information 2012/10/12
Last modified on 2017/11/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)
Acronym Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)
Scientific Title Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)
Scientific Title:Acronym Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)
Region
Japan

Condition
Condition advanced or recurrent breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the time to treatment failure and safty of Paclitaxel with Bevacizumab for advanced or recurrent breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes time to treatment failure
Key secondary outcomes overall survival

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Treatment with Bevacizumab planned case
1-1.Histologically diagnosed with uniateral primary or recurrent breast cancer
1-2.>=20years old
1-3.No previous treatment with Bevacizumab
1-4.If hospital need written informed consent,is taken
2.In treatment with Bevacizumab case
2-1.Histologically diagnosed with uniateral primary or recurrent breast cancer
2-2.>=20years old
2-3.During treatment with Bevacizumab
2-4.If hospital need written informed consent,is taken
3.After treatment with Bevacizumab case
3-1.Histologically diagnosed with uniateral primary or recurrent breast cancer
3-2.>=20years old
3-3.Afer treatment with Bevacizumab
3-4.If hospital need written informed consent,is taken
Key exclusion criteria Only treatment with Bevacizumab planned case
4-1.Have hypersensitivity to Bevacizumab
4-2.During pregnancy or lactation
4-3.Patients receiving anticoagulant therapy
4-4.Daily treatment with hight-dose aspirin(>=325mg/day) or non-steroidal anti-inflammatory medications for chronic inflammatory disease
4-5.Bleeding tendency(including significant hemoptysis or pulmonary tumor cavitation and necrosis),(INR>=1.5 within two weeks prior to entry)
4-6.Uncontrolled peptic ucer
4-7.Perforation of gastrointestional tract within one year
4-8.Renal failure to treated,2+ or higher proteinuria within two weeks prior to entry
4-9.Uncontrolled hypertension
4-10.Clinically significant cardiovascular disease(>=Grade2 according to the Common Toxicity Criteria of the National Cancer Institute,version 4), clinically important echocardiographic findigs,or past or current history(within the last one year)of myocardial infarction
4-11.Not appropriate for the study at the physician's assessment
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Inoue Kenichi
Organization Saitama Cancer Center
Division name Breast Cancer Oncology
Zip code
Address 818 Komuro Ina-machi Kitaadachi-gun Saitama 362-0806
TEL 048-722-1111
Email ino@cancer-c.pref.saitama.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Kai
Organization Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name Secretariat Division (Shintoshin Ladies' MammoClinic)
Zip code
Address 3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL 048-600-1722
Homepage URL http://www.sbccsg.org/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 埼玉県立がんセンター(埼玉県),さいたま赤十字病院(埼玉県),埼玉社会保険病院(埼玉県),埼玉医大総合医療センター(埼玉県),自治医大さいたま医療センター(埼玉県)赤心堂病院(埼玉県),三井病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the time to treatment failure and safty of Paclitaxel with Bevacizumab for advanced or recurrent breast cancer

Management information
Registered date
2012 Year 10 Month 11 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010665

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.