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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014445
Receipt No. 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

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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
Email 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
Email kikuchiy-sur@h.u-tokyo.ac.jp

Sponsor
Institute Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016806

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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