UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients
Title of the study (Brief title)	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 evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	clinical benefit rate of biweekly iv
Key secondary outcomes	safety of biweekly iv time to treatment failure of biweekly iv overall survival of biweekly iv clinical benefit rate of 1.4mg/m2 day1,8 iv every 3 weeks safety of 1.4mg/m2 day1,8 iv every 3 weeks time to treatment failure of 1.4mg/m2 day1,8 iv every 3 weeks overall survival of 1.4mg/m2 day1,8 iv every 3 weeks

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	eriburin 1.4mg/m2 day1,8 iv every 3 weeks.1.4mg/m2 biweekly iv is performed when not meeting the entry criteria by 2nd cycle Day1.
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	(1) advanced or recurrent breast cancer (2) previous treatment with anthracyclines and taxanes (3) aged 20 and over (4) HER2-negative breast cancer (5) ECOG performance status 0-2 (6) having measurable lesion according to RECIST version 1.1 (7) suffient organ function(e.g. marrow,liver, kidney,bone) (8) expected survival time more than 3 months (9) written informed consent
Key exclusion criteria	(1) infectious disease with fever (2) heart failure with clinically problem. significant interstitial pneumonia or pulmonary fibrosis by chest radiograph (3) pleural effusion, peritoneal effusion (4) presence of the active other malignancies (5) poorly controlled diabetes mellitus(6) brain metastasis with symptom (7) pregnant or nursing women (8) physician judged improper to entry this trial
Target sample size	80

Research contact person
Name of lead principal investigator	Shoichiro Ohtani
Organization	Hiroshima City Hospital
Division name	Breast Surgery
Address	7-33 Motomachi, Naka-ku, Hiroshima-shi, Hiroshima-ken
TEL
Email

Public contact
Name of contact person
Organization	NPO Advanced Clinical Reserch Organization
Division name	Executive Office
Address
TEL
Homepage URL	http://www.npo-acro.jp/
Email

Sponsor
Institute	NPO Advanced Clinical Reserch Organization
Institute
Department

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)

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	2012 Year 07 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 30 Day
Anticipated trial start date	2012 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 21 Day
Last modified on	2018 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009978