UMIN-CTR Clinical Trial

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
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Interventions/Control_2
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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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