UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006086 |
|---|---|
| Receipt number | R000007037 |
| Scientific Title | Efficacy and safety of Eribulin as the first line therapy for advanced or recurrent breast cancer patients without HER2 overexpression. |
| Date of disclosure of the study information | 2011/07/31 |
| Last modified on | 2016/06/12 16:35:15 |
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Basic information
Public title
Efficacy and safety of Eribulin as the first line therapy for advanced or recurrent breast cancer patients without HER2 overexpression.
Acronym
BIRICHEN study(Breast cancer multi Institutional study for Recurrent or Inoperable patients by first line CHemotherapy with EribuliN)
Scientific Title
Efficacy and safety of Eribulin as the first line therapy for advanced or recurrent breast cancer patients without HER2 overexpression.
Scientific Title:Acronym
BIRICHEN study(Breast cancer multi Institutional study for Recurrent or Inoperable patients by first line CHemotherapy 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
To evaluate efficacy and safety of Eribulin in advanced or recurrent breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
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
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1)patient who confirmed histologically HER2 negative as metastatic breast cancer
2)ferst-line chemotherapy
3)ECOG PS 0-1
4)having measureable lesion according to RECIST
5)adequate organ functions confermed with following major examination
neutrophil=>1500mm3
platelet count=>100,000/mm3
hemoglobin=>9.0g/dL
AST,ALT=<75IU/L
total bilirubin=<1.5mg/dL
serum creatinine=<1.5mg/dL
6)Expected survival time : more than 3 months
7)obtained written informed consent
Key exclusion criteria
1)having systemic infection
2)pleural effusion,ascites,hydropericardium that is not good control
3)symptomatic brain metastasis
4)patient with following serious complication
heart disease that is not good control
myocardial infarction in the latest 6th months
cirrhosis
interstitial pneumonia,pulmonary fibrosis
bleeding tendency
5)having active multiple cancers
6)menopausal women patients having possibility pregnancy
7)systemic steroid therapy
8)widespread radiation therapy
9)patient who reject supportive therapy for myelosuppresion
10)judged by the investigator to be unfit to be enrolled into the study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takashima |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-4-3,Asahimachi,Abeno-ku,Osaka
TEL
06-6645-3838
tsutuomu-@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takashima |
Organization
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
Division name
Executive office
Zip code
Address
1-4-3 Asahimachi Abeno-Ku Osaka Japan
TEL
06-6645-3838
Homepage URL
tsutomu-@rd5.so-net.ne.jp
Sponsor or person
Institute
Dept. Surgical Oncology, Osaka City 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
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
| 2011 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://springerplus.springeropen.com/articles/10.1186/s40064-016-1833-1
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
Main results already published
Date of protocol fixation
| 2011 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 31 | Day |
Last modified on
| 2016 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007037
