UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023300 |
|---|---|
| Receipt number | R000026723 |
| Scientific Title | Investigation of the effect of eribulin mesilate on epithelial-mesenchymal transition in tumors of patients with metastatic breast cancer |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2020/07/27 09:03:06 |
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Basic information
Public title
Investigation of the effect of eribulin mesilate on epithelial-mesenchymal transition in tumors of patients with metastatic breast cancer
Acronym
FAS-01 study
Scientific Title
Investigation of the effect of eribulin mesilate on epithelial-mesenchymal transition in tumors of patients with metastatic breast cancer
Scientific Title:Acronym
FAS-01 study
Region
| Japan |
Condition
Condition
metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to
investigate the effect of eribulin on epithelial-mesenchymal transition (EMT) and vitamin D receptor in tumors of metastatic breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change from baseline to day 15+-4 in expression of EMT related markers and vitamin D receptor in tumor tissue
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eribulin (1.4 mg/m2) is administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Dose reductions and dose delays are allowed according to eribulin's prescribing information or physician's choice.
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
Female
Key inclusion criteria
1)Histologically or cytologically confirmed breast cancer
2)ECOG performance status(PS)0~2
3)Discontinuation of previous treatment
chemotherapy: 4 weeks (If previous chemotherapy is not effective, 2 weeks is possible for inclusion)
radiation: 2 weeks
4)Measurable disease
5)No history of eribulin treatment
6)Adequate organ function
Meet the criteria of baseline laboratory parameters as bellows.
WBC:3,000/mm3 or more, or neutrophils:1,500/mm3 or more
platelets:100,000mm3 or more
Hb:9.0g/dL or more
Total bilirubin:2.0 mg/dL or less
AST (GOT), ALT (GPT):within 2.5 ULN
in patients with liver metastasis, within 5 ULN
creatinine:1.5 mg/dL or less
7)Expected to have more than 3 months of survival
8)without medical problem in ECG
9)Written informed consent
Key exclusion criteria
1)Patients with infection or patients with fever and suspected infection
2)Patient with watery diarrhea, bowel paralysis or ileus
3)Patients with fresh bleeding from gastrointestinal tract
4)History of severe drug allergy
5)Patients with severe renal dysfunction or liver dysfunction
6)Patients with interstitial pneumonia or pulmonary fibrosis revealed on chest X-rays
7)Patients with massive pleural effusion or ascites that need to be drained
8)Patients with poorly controlled hypertension or diabetes
9)Patients administrated continuously steroids for long term
10)Pregnant
11)Other active malignancies excluding carcinoma in situ cured by local treatment
12)History of severe mental disorder or central nervous system disorder
13)Patients who are judged to be inappropriate as an object for this treatment by physicians
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Utsumi |
Organization
Fujita Health University
Division name
Department of breast surgery
Zip code
470-1192
Address
1-98 dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2111
tutsumi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Utsumi |
Organization
Fujita Health University
Division name
Department of breast surgery
Zip code
470-1192
Address
1-98 dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2111
Homepage URL
tutsumi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Fujita Health University
Address
1-98 dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
Tel
0562-932865
f-rib@fujita-hu.ac.jp
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 | 08 | 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
22
Results
Erbulin could suppress EMT in some breast cancer.
Results date posted
| 2020 | Year | 07 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with inoperable or recurrent breast cancer
Participant flow
Adverse events
Outcome measures
Change in protein expression of epithelial-mesenchymal transition markers in tumor tissue
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 27 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 27 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026723
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