UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027527 |
|---|---|
| Receipt number | R000031554 |
| Scientific Title | Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients |
| Date of disclosure of the study information | 2017/05/29 |
| Last modified on | 2019/05/31 11:27:54 |
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Basic information
Public title
Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients
Acronym
Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients.
Scientific Title
Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients
Scientific Title:Acronym
Exploratory clinical study of eribulin followed by taxane for metastatic breast cancer patients.
Region
| Japan |
Condition
Condition
Metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of eribulin followed by taxane in patients with metastatic breast cancer.
(Comparison of literature data)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TTP(Time to progression) of taxane after administration of eribulin.
(Comparison of literature data)
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients of administerd taxane after eribulin in 1st or 2nd line chemotherapy for metastatic breast cancer.
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1)metastatic breast cancer(HER2-)
2)ECOG performance status 0-1
3)The presence of at least one measurable lesion
4)The patients with the measurable lesion by RECIST1.1
5)The patients of eribulin followed by taxane
6)The patients with adequate organ function
neutrophil count>1000
Platelet count>75,000
Hemoglobin>9.0
AST/ALT<=75
Total bilirubin<1.5
Serum creatinine<1.5
7)Age>=20years,<80years
8)Written informed concent
Key exclusion criteria
1)HER2+
2)Concurrent active infections
3)The presence of brain metastasis requiring treatment
4)Sever complications
Current uncontorolled CHF
History of myocardial infractionwithin 6 months of randomization
Cirrhosis of the liver
Interstitial pneumonaitis
Hemorrhagic Diathesis
5)Patients with synchronous double cancer
6)Pregnant or nursing women or who suspected pregnant
7)The patients combination has been chemotherapy,immunotherapy,hormone therapy,radiation therapy and surgical treatment
8)Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1Minamikogushi,Ube,Yamaguchi 755-8505 Japan
TEL
083-622-2264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Maeda |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
755-8505
Address
1-1-1Minamikogushi,Ube,Yamaguchi 755-8505 Japan
TEL
083-622-2264
Homepage URL
nsampei@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
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
Yamaguchi University Graduate School of Medicine
Address
1-1-1Minamikogushi,Ube,Yamaguchi 755-8505 Japan
Tel
0836-22-2428
clin_res@yamaguchi-u.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
| 2017 | Year | 05 | Month | 29 | 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
| 2017 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 29 | 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
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031554
