UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of early phase eribulin for metastatic breast cancer.
Acronym	KOEB
Scientific Title	A phase II trial of early phase eribulin for metastatic breast cancer.
Scientific Title:Acronym	KOEB
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of early phase eribulin for locally advanced and metastatic breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	objective response rate
Key secondary outcomes	progression free survival, overall survival, safety

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	administration of eribulin 1.4mg/m2 on day1 and day8 every 3 weeks
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1)Histologically or cytologically confirmed breast cancer. 2)ECOG performance status 0-2 3)Measurable disease 4)Three or less regimens of chemotherapy for breast cancer and one or less regimen of chemotherapy for locally advanced or metastatic breast cancer 5)No history of eribulin treatment 6) Meet the cirteria of baseline labolatory parameters as below. Netrophils count 1500/mm3 or more, Plt 100,000/mm3 or more, Hb 9g/dl or more, T.Bil 2mg/dl or less, GOT and GPT within 2.5ULN, CRN 1.5mg/dL or less, 7)Expected to have more than 3 months of survival 8)Normal ECG 9)Written informed consent
Key exclusion criteria	1)Patients with infection or fever 2)History of severe allergy 3)History of renal or liver failure 4)Patients with interstitial pneumonia or pulmonary fibrosis diagnosed by chest X ray 5)Patients with pleural effusion of ascites that needs to be treated 6)Patients with hypertention or diabetes that are not controlled by medication 7)Administration of systemic steroids 8)Pregnancy 9)Patients who had transfusion or injection of G-CSF within 7 days before the treatment 10)Other active malignancies 11)Clinically significant mental disorder 12)CNS involvement 13)Participants of other treatment protocol 14)Other medical conditions that could limit a patient's ability to undertake study therapy
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hirofumi Kawakubo
Organization	Keio University School of Medicine
Division name	Department of surgery
Zip code
Address	35 Shinanomachi Shinjuku Tokyo
TEL	03-3353-1211
Email	mmk_csaito@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Chisato Saito
Organization	Keio University School of Medicine
Division name	Department of surgery
Zip code
Address	35 Shinanomachi, Shinjuku, Tokyo Japan
TEL	03-3353-1211
Homepage URL
Email	mmk_csaito@yahoo.co.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine Department of surgery breast group
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	東京医療センター(東京都)、足利赤十字病院(栃木県)、水戸赤十字病院（茨城県）、那須赤十字病院（栃木県）、済生会宇都宮病院（栃木県）、公立福生病院（東京都）、共済組合立川病院（東京都）、北里研究所病院（東京都）、けいゆう病院（神奈川県）、平塚市民病院（神奈川県）、大和市立病院（神奈川県）、済生会神奈川病院（神奈川県）、済生会横浜市東部病院（神奈川県）、さいたま市立病院（埼玉県）、埼玉社会保険病院（埼玉県）、東京歯科大学市川病院（千葉県）、佐野厚生病院（栃木県）、川崎市立川崎病院（神奈川県）、川崎市立井田病院（神奈川県）、日野市立病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 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	2013 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date	2013 Year 03 Month 27 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	2013 Year 03 Month 27 Day
Last modified on	2015 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012097

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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