![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | Advanced or metastatic breast cancer | |
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
Organization | Osaka Medical College | ||||||
Division name | Breast Surgery | ||||||
Zip code | |||||||
Address | 2-7 Daigakumachi, Takatsuki City, Osaka, Japan | ||||||
TEL | 072-683-1221 | ||||||
sur121@osaka-med.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Osaka Medical College | ||||||
Division name | Breast Surgery | ||||||
Zip code | |||||||
Address | 2-7 Daigakumachi, Takatsuki City, Osaka, Japan | ||||||
TEL | 072-683-1221 | ||||||
Homepage URL | |||||||
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |