UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002491 |
|---|---|
| Receipt number | 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 17:44:08 |
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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
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
surgery2@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003056
