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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009084
Receipt No. R000010659
Scientific Title Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Date of disclosure of the study information 2012/10/11
Last modified on 2018/04/17

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Basic information
Public title Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Acronym Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Scientific Title Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Scientific Title:Acronym Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Region
Japan

Condition
Condition advanced or reccurent breast cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the benefit of bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Time to treatment failure
Dose intensity(mg/m2/week)
Key secondary outcomes Overall response rate
Progression free survival
Clinical benefit rate
Safety(AE)
Dose

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 One cycle consists of 4 weeks.
Eribulin will be administrated intravenously on day1 and 15.
Administration can be continued until the evidence of desease progression or unacceptable toxcity.
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)Administrated 1.4mg/m2 on day1 and skipped on day8 due to administration criteria
2)Satisfied administration criteria on day15
3)Female with hisitologically or citologically confirmed breast cancer
4)Aged 20-years when giving informed consent
5)ECOG perfomance status(PS) 0-2
6)With measurable lesion met the RECIST criteria and evaluated baseline within 30days before Eribulin first treatment
7)Have received anthracycline and taxan
8)Have no carryover of efficacy or no adverse drug reactions from previous therapy
9)With adequate function of major organs
10)With an expected survival of >= 3 months from Eribulin first treatment
11)Planed with eribulin monotherapy
12)Have given wriiten voluntary concent for participation in this study
Key exclusion criteria 1)Systemic infection
2)Dirrea, ileus
3)GI bleeding
4)Sever drug allergy
5)Sever renal and/or liver disfunction
6)Significant interstitial pneumonia or plumonary fibrosis by chest X-P
7)Pleural effusion, peritoneal effusion
8)Uncontrolled hypertension or diabetes mellitus
9)Maintenance therapy with systemic corticosteroids
10)Pregnant women or women with suspected pregnancy
11)Active double cancer
12)Severe psychiatric disorder
13)Active brain metastases
14)Participating in other chemotherapy or study
15) Judeged by the investigator to be unfit for this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Narui
Organization Yokohama City University Medical Center
Division name Breast and thyroid surgery
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email nr1@gc5.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Narui
Organization Yokohama City University Medical Center
Division name Breast and thyroid surgery
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email nr1@gc5.so-net.ne.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
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
2012 Year 10 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www2.convention.co.jp/25jbcs/
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 08 Month 08 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 11 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 11 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010659

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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