UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Title of the study (Brief title)	Study to evaluate the bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Region	Japan

Condition
Condition	advanced or reccurent breast cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the benefit of bi-weekly schedule of eribulin for patients with advanced or reccurent breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Time to treatment failure Dose intensity(mg/m2/week)
Key secondary outcomes	Overall response rate Progression free survival Clinical benefit rate Safety(AE) Dose

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	One cycle consists of 4 weeks. Eribulin will be administrated intravenously on day1 and 15. Administration can be continued until the evidence of desease progression or unacceptable toxcity.
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)Administrated 1.4mg/m2 on day1 and skipped on day8 due to administration criteria 2)Satisfied administration criteria on day15 3)Female with hisitologically or citologically confirmed breast cancer 4)Aged 20-years when giving informed consent 5)ECOG perfomance status(PS) 0-2 6)With measurable lesion met the RECIST criteria and evaluated baseline within 30days before Eribulin first treatment 7)Have received anthracycline and taxan 8)Have no carryover of efficacy or no adverse drug reactions from previous therapy 9)With adequate function of major organs 10)With an expected survival of >= 3 months from Eribulin first treatment 11)Planed with eribulin monotherapy 12)Have given wriiten voluntary concent for participation in this study
Key exclusion criteria	1)Systemic infection 2)Dirrea, ileus 3)GI bleeding 4)Sever drug allergy 5)Sever renal and/or liver disfunction 6)Significant interstitial pneumonia or plumonary fibrosis by chest X-P 7)Pleural effusion, peritoneal effusion 8)Uncontrolled hypertension or diabetes mellitus 9)Maintenance therapy with systemic corticosteroids 10)Pregnant women or women with suspected pregnancy 11)Active double cancer 12)Severe psychiatric disorder 13)Active brain metastases 14)Participating in other chemotherapy or study 15) Judeged by the investigator to be unfit for this study
Target sample size	20

Research contact person
Name of lead principal investigator	Kazutaka Narui
Organization	Yokohama City University Medical Center
Division name	Breast and thyroid surgery
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	nr1@gc5.so-net.ne.jp

Public contact
Name of contact person	Kazutaka Narui
Organization	Yokohama City University Medical Center
Division name	Breast and thyroid surgery
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	nr1@gc5.so-net.ne.jp

Sponsor
Institute	Yokohama City University Medical Center
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)

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	2012 Year 10 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 08 Day
Anticipated trial start date	2012 Year 10 Month 11 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www2.convention.co.jp/25jbcs/
Results
Other related information

Management information
Registered date	2012 Year 10 Month 11 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010659