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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006086
Receipt No. 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

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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
Email 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
Email tsutomu-@rd5.so-net.ne.jp

Sponsor
Institute Dept. Surgical Oncology, Osaka City University Graduate School of Medicine
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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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