UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008491 |
|---|---|
| Receipt number | R000009978 |
| Scientific Title | Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients |
| Date of disclosure of the study information | 2012/07/28 |
| Last modified on | 2018/05/07 16:40:43 |
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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
Acronym
JUST-STUDY
Scientific Title
Japanese study to evaluate the utility of eribulin dose and schedule in treatment for advanced breast cancer patients
Scientific Title:Acronym
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
| 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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
NPO Advanced Clinical Reserch Organization
Division name
Executive Office
Zip code
Address
TEL
Homepage URL
http://www.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
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 |
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
| 2012 | Year | 06 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009978
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
