UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027714 |
|---|---|
| Receipt number | 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 | 2022/12/15 10:36:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Mitsuhiko |
| Middle name | |
| Last name | Iwamoto |
Organization
Osaka Medical College
Division name
Breast Surgery
Zip code
5698686
Address
Daigakumachi 2-7, Takatsuki city
TEL
0726831221
k.kosei66@gmail.com
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Kimura |
Organization
Osaka medical college
Division name
Breast Surgery
Zip code
5698686
Address
Daigakumachi 2-7, Takatsuki city
TEL
0726831221
Homepage URL
k.kosei66@gmail.com
Sponsor or person
Institute
Breast Surgery, Osaka Medical College
Institute
Department
Personal name
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
Osaka Medical College
Address
2-7 Daigakumachi, Takatsuki City, Osaka, Japan
Tel
0726831221
k.kosei66@gmail.com
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
Terminated
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 13 | Day |
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
| 2022 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031749
