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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014158
Receipt No. 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

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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
Email 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
Email t-kotake@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016485

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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