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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027714
Receipt No. R000031749
Scientific Title Analysis of serum epithelium mesenchymal system marker for advanced or metastatic breast cancer treated with Eribulin
Date of disclosure of the study information 2017/07/01
Last modified on 2017/06/10

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Basic information
Public title Analysis of serum epithelium mesenchymal system marker for advanced or metastatic breast cancer treated with Eribulin
Acronym Analysis of serum epithelium mesenchymal system marker for advanced or metastatic breast cancer treated with Eribulin
Scientific Title Analysis of serum epithelium mesenchymal system marker for advanced or metastatic breast cancer treated with Eribulin
Scientific Title:Acronym Analysis of serum epithelium mesenchymal system marker for advanced or metastatic breast cancer treated with Eribulin
Region
Japan

Condition
Condition Advanced or metastatic breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Analysis of serum epithelium mesenchymal system marker for advanced or metastatic breast cancer treated with Eribulin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Comparison between change of serum epithelium mesenchymal system marker and clinical response after 3 cycles of Eribulin
Key secondary outcomes Objective Response Rate, Duration of Response, Progression free survival, Overall survival, 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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. histlogically or cytologically confirmed breast cancer 2. advanced or metastatic breast cancer patient treated with Eribulin 3. required baseline laboratory parameters (within 1 weeks before registration) WBC >3,000/mm3 neutrophi > 1,500/mm3 Plt > 100,000/mm3 Hb >9.0g/dL AST <2.0 times ULN and ALT <2.0 times ULN serum
creatinine <1.5 time ULN normal cardiac function 4. with life expectancy greater than 3 months 5. written informed consent was obtained
Key exclusion criteria 1. serious complication or past history:
with symptomatic heart failure,
ischemic heart disease within 6 months,
liver cirrhosis,
psychological disorder treated by antipsychotic drug,
uncontrolable diabetes, etc
2. active infection
3. The anamnesis of the hypersensitivity to Eribulin
4. peripheral neuropathy greater than Grade 3
5. male breast cancer
6. under pregnancy or breast-feeding, and possibility (will) of pregnancy.
7. with doctors decision for exclusion
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiko Iwamoto
Organization Osaka Medical College
Division name Breast Surgery
Zip code
Address 2-7 Daigakumachi, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Email sur121@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kosei Kimura
Organization Osaka Medical College
Division name Breast Surgery
Zip code
Address 2-7 Daigakumachi, Takatsuki City, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email sur121@osaka-med.ac.jp

Sponsor
Institute Breast Surgery, Osaka Medical College
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 大阪医科大学

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information not particular

Management information
Registered date
2017 Year 06 Month 10 Day
Last modified on
2017 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031749

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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