UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014158 |
|---|---|
| Receipt number | R000016485 |
| Scientific Title | The analysis of Eribulin in patients with unresectable breast cancer, retorospective multicenter study |
| Date of disclosure of the study information | 2014/06/07 |
| Last modified on | 2014/10/23 20:37:41 |
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Basic information
Public title
The analysis of Eribulin in patients with unresectable breast cancer, retorospective multicenter study
Acronym
Kyoto ABC Cohort Study 01
Scientific Title
The analysis of Eribulin in patients with unresectable breast cancer, retorospective multicenter study
Scientific Title:Acronym
Kyoto ABC Cohort Study 01
Region
| Japan |
Condition
Condition
HER2-negative Unresectable breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of Eribulin for HER2-negative unresectable breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The patients of HER2-negative unresectable breast cancer with Eribulin treatment.
Key exclusion criteria
none.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Kikawa |
Organization
Kobe City Medical Center General Hospital
Division name
department of breast surgery
Zip code
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL
078-302-4321
u-1ro@kcho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kotake |
Organization
Kobe City Medical Center General Hospital
Division name
medical oncology
Zip code
Address
2-1-1, Minatojima minamimachi,chuo-ku,Kobe city,Hyogo 650-0047 Japan
TEL
078-302-4321
Homepage URL
t-kotake@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
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
神戸市立医療センター中央市民病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 30 | Day |
Other
Other related information
retrospective-multicenter cohort study
Management information
Registered date
| 2014 | Year | 06 | Month | 03 | Day |
Last modified on
| 2014 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016485
