UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022362 |
|---|---|
| Receipt number | R000025718 |
| Scientific Title | A Phase II, Open-label, Multicenter, Translational Study for Biomarkers of Eribulin Mesylate: Evaluation of the Utility of Monitoring Epithelial-to-Mesenchymal Transition (EMT) Markers on Tumor Cells in the Malignant Plural Effusion of Patients with Metastatic Breast Cancer |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/09/28 10:16:58 |
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Basic information
Public title
A Phase II, Open-label, Multicenter, Translational Study for Biomarkers of Eribulin Mesylate: Evaluation of the Utility of Monitoring Epithelial-to-Mesenchymal Transition (EMT) Markers on Tumor Cells in the Malignant Plural Effusion of Patients with Metastatic Breast Cancer
Acronym
EXPECT-study
Scientific Title
A Phase II, Open-label, Multicenter, Translational Study for Biomarkers of Eribulin Mesylate: Evaluation of the Utility of Monitoring Epithelial-to-Mesenchymal Transition (EMT) Markers on Tumor Cells in the Malignant Plural Effusion of Patients with Metastatic Breast Cancer
Scientific Title:Acronym
EXPECT-study
Region
| Japan |
Condition
Condition
Metastatic Breast Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In MBC patients with malignant pleural effusion, to establish EMT/MET markers using the cancer cells in the pleural effusion,and to verify the EMT/MET markers as biomarkers in eribulin monotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Changes in EMT/MET marker expression between pre- and post-treatment
Key secondary outcomes
Relationship between these changes and the clinical outcome: clinical benefit rate, progression-free survival, and overall survival,
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eribulin will be administered at 1.4 mg/m2 on Days (D) 1 and 8 for a 3-week cycle (C) until disease progression or appearance of unmanageable side effect. Concurrent use of anti-HER2 monoclonal antibody will be allowed.
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
Male and Female
Key inclusion criteria
1) Histologically, cytologically or clinically confirmed MBC
2) Indication of eribulin monotherapy
3) Signed informed consent
4) Age>=20 years
5) Clinically diagnosed as having MPE
6) Indication of MPE drainage
7) Eastern Cooperative Oncology Study Group performance status 0 to 2
8) Having at least one measurable disease or non-measurable bone only diseas as defined by Response Evaluation Criteria in Solid Tumors vesion 1.1
9) Adequate organ function (heart, lung, liver, kidney, bone marrow)
10) Discontinuation of previous therapy (systemic or local) at least 2 weeks proir to enrollment
Key exclusion criteria
1) History of eribulin therapy
2) Pregnant, lactating or woman not agree with contraception within the study period
3) CNS metastasis with symptom or require treatment
4) Active infection excluding well-controlled chronic hepatitis B infection
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichiro Watanabe |
Organization
Shizuoka Cancer Center
Division name
Breast Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi, Shizuoka, Japan
TEL
055-989-5222
j.watanabe@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Izumi Hirata |
Organization
Shizuoka Cancer Center
Division name
Breast Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
i.hirata@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Organization for Creation of Industries (Pharma Valley Center)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Eisai Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 19 | Day |
Last modified on
| 2016 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025718
