UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019137
Receipt number R000022124
Scientific Title Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-
Date of disclosure of the study information 2015/09/28
Last modified on 2018/05/07 16:39:51

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Basic information

Public title

Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-

Acronym

Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-

Scientific Title

Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-

Scientific Title:Acronym

Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients(JUST-STUDY)-additional research on patients enrolled in JUST-STUDY-

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To do additional research on safety and efficacy of 88 patients enrolled in JUST-study, for further discussion of bi-weekly eribulin therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Time to Treatment Failure(TTF) of bi-weekly patients

Key secondary outcomes

Overall survival(OS), safety


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

20 years-old <=

Age-upper limit


 Not applicable

Gender

Female

Key inclusion criteria

All who enrolled in JUST-STUDY

Key exclusion criteria

none

Target sample size

88


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoichiro Ohtani

Organization

Hiroshima City Hospital

Division name

Breast Surgery

Zip code


Address

7-33, Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken

TEL

082-22102291

Email

eriburlin-study@npo-acro.jp


Public contact

Name of contact person

1st name
Middle name
Last name JUST-STUDY Executive Office

Organization

NPO Advanced Clinical Reserch Organization

Division name

JUST-STUDY Executive Office

Zip code


Address

2-10-3,kotobukicho,Fuchu,Tokyo

TEL

042-352-7676

Homepage URL


Email

eriburlin-study@npo-acro.jp


Sponsor or person

Institute

NPO Advanced Clinical Reserch Organization

Institute

Department

Personal name



Funding Source

Organization

NPO Advanced Clinical Reserch Organization

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 28 Day


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 07 Month 23 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

a


Management information

Registered date

2015 Year 09 Month 28 Day

Last modified on

2018 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022124


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name