UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of Eribulin as the first line therapy for advanced or recurrent breast cancer patients without HER2 overexpression.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Tsutomu Takashima
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Surgical Oncology
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	Tsutomu Takashima
Organization	Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
Division name	Executive office
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://springerplus.springeropen.com/articles/10.1186/s40064-016-1833-1
Results
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