UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical efficacy of Eribulin new for metastatic breast cancer
Title of the study (Brief title)	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	Tada Keiichirou
Organization	Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Division name	Breast and Endocrine Surgery Department
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	Kikuchi Yasuko
Organization	Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
Division name	Breast and Endocrine Surgery Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/doi/full/10.1111/ajco.12863
Results
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/icdr_e/ctr_view.cgi?recptno=R000016806