UMIN-CTR Clinical Trial

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
Last 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
Email	hnagano@yamaguchi-u.ac.jp

Public contact
1st 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
Email	nsampei@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi 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	Yamaguchi University Graduate School of Medicine
Address	1-1-1Minamikogushi,Ube,Yamaguchi 755-8505 Japan
Tel	0836-22-2428
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031554