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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002491
Receipt No. R000003056
Scientific Title Multicenter study about an effect of Vinorelbine for recurrent brteast cancer
Date of disclosure of the study information 2009/12/01
Last modified on 2009/09/14

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Basic information
Public title Multicenter study about an effect of Vinorelbine for recurrent brteast cancer
Acronym Naberubine study
Scientific Title Multicenter study about an effect of Vinorelbine for recurrent brteast cancer
Scientific Title:Acronym Naberubine study
Region
Japan

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

Objectives
Narrative objectives1 efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes tumor size
Key secondary outcomes side effect

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 chemotherapy
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
75 years-old >
Gender Female
Key inclusion criteria recurrent breast cancer patient
PS as 0-1
Key exclusion criteria poor prognoses and poor PS
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tangoku
Organization Tokushima University Hospital
Division name Department of esophageal, breast and thyroid diseases
Zip code
Address Kuramoto 2-50-1
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Tangoku
Organization Tokushima University Hospital
Division name Department of esophageal, breast and thyroid diseases
Zip code
Address Kuramoto 2-50-1
TEL 088-633-7143
Homepage URL
Email surgery2@clin.med.tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Kyouwa Hakko Kirin Co. Ltd>
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 徳島大学病院

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2009 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 14 Day
Last modified on
2009 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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