UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014445 |
|---|---|
| Receipt number | R000016806 |
| Scientific Title | Clinical efficacy of Eribulin new for metastatic breast cancer |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2018/04/01 14:46:12 |
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Basic information
Public title
Clinical efficacy of Eribulin new for metastatic breast cancer
Acronym
Clinical efficacy of Eribulin new for metastatic breast cancer
Scientific Title
Clinical efficacy of Eribulin new for metastatic breast cancer
Scientific Title:Acronym
Clinical efficacy of Eribulin new for metastatic breast cancer
Region
| Japan |
Condition
Condition
progressive or metastatic breast cancer patients
Classification by specialty
| Endocrine surgery | Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of using Eribrin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OS,PFS
Key secondary outcomes
ORR,TTF,adverse ebents
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For breast cancer metastasis cases, cases it was invalid be administered an anti-cancer agent anthracycline, taxane-based in the designated facilities.
Key exclusion criteria
Patients who sustain adverse events using after taxanes.
Patients who have not enough judgment ability minors, in adults, cases of acquisition agreement by the description document is difficult.
Patients who are subjected to treatment without their doctors not revealing the breast cancer treatment.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tada Keiichirou |
Organization
Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Division name
Breast and Endocrine Surgery Department
Zip code
Address
Hongo, 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9538
TADAK-SUR@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kikuchi Yasuko |
Organization
Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Division name
Breast and Endocrine Surgery Department
Zip code
Address
Hongo, 7-3-1, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9538
Homepage URL
kikuchiy-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Organization
Division
Category of Funding Organization
Other
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
国際医療福祉大学三田病院（東京都）、公立昭和病院（東京都）、国立国際医療センター（東京都）、虎ノ門病院（東京都）、関東中央病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/ajco.12863
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
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
Analysis about background of the patient being administered,occurrence of adverse events, presence or absence of pre-treatment, administration period, during treatment, the treatment duration of response, analysis of tumor reduction rate of the image evaluation
Management information
Registered date
| 2014 | Year | 07 | Month | 01 | Day |
Last modified on
| 2018 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016806
