UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II, Open-label, Multicenter, Translational Study for Biomarkers of Eribulin Mesylate: Evaluation of the Utility of Monitoring Epithelial-to-Mesenchymal Transition (EMT) Markers on Tumor Cells in the Malignant Plural Effusion of Patients with Metastatic Breast Cancer
Title of the study (Brief title)	EXPECT-study
Region	Japan

Condition
Condition	Metastatic Breast Cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In MBC patients with malignant pleural effusion, to establish EMT/MET markers using the cancer cells in the pleural effusion,and to verify the EMT/MET markers as biomarkers in eribulin monotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Changes in EMT/MET marker expression between pre- and post-treatment
Key secondary outcomes	Relationship between these changes and the clinical outcome: clinical benefit rate, progression-free survival, and overall survival,

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eribulin will be administered at 1.4 mg/m2 on Days (D) 1 and 8 for a 3-week cycle (C) until disease progression or appearance of unmanageable side effect. Concurrent use of anti-HER2 monoclonal antibody will be allowed.
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	Male and Female
Key inclusion criteria	1) Histologically, cytologically or clinically confirmed MBC 2) Indication of eribulin monotherapy 3) Signed informed consent 4) Age>=20 years 5) Clinically diagnosed as having MPE 6) Indication of MPE drainage 7) Eastern Cooperative Oncology Study Group performance status 0 to 2 8) Having at least one measurable disease or non-measurable bone only diseas as defined by Response Evaluation Criteria in Solid Tumors vesion 1.1 9) Adequate organ function (heart, lung, liver, kidney, bone marrow) 10) Discontinuation of previous therapy (systemic or local) at least 2 weeks proir to enrollment
Key exclusion criteria	1) History of eribulin therapy 2) Pregnant, lactating or woman not agree with contraception within the study period 3) CNS metastasis with symptom or require treatment 4) Active infection excluding well-controlled chronic hepatitis B infection
Target sample size	48

Research contact person
Name of lead principal investigator	Junichiro Watanabe
Organization	Shizuoka Cancer Center
Division name	Breast Oncology
Address	1007 Shimonagakubo, Nagaizumi, Shizuoka, Japan
TEL	055-989-5222
Email	j.watanabe@scchr.jp

Public contact
Name of contact person	Izumi Hirata
Organization	Shizuoka Cancer Center
Division name	Breast Oncology
Address	1007 Shimonagakubo, Nagaizumi, Shizuoka, Japan
TEL	055-989-5222
Homepage URL
Email	i.hirata@scchr.jp

Sponsor
Institute	Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Shizuoka Organization for Creation of Industries (Pharma Valley Center)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Eisai Co., Ltd.

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	2016 Year 06 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 01 Month 02 Day
Anticipated trial start date	2016 Year 04 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 19 Day
Last modified on	2016 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025718