UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety trial of eriburin treatment to patient who has peripheral neuropathy
Title of the study (Brief title)	H(Hiroshima)-STEP
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety of Eribulin in breast cancer patients with peropheral neuropathy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence rates of peripheral neuropathy G3(CTCAE)
Key secondary outcomes	Response Rate Overall Survival FACT-NTX EQ-5D Safety PNQ

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	1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
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) Histologically or cytologically confirmed breast cancer. 2) Unresectable metastatic breast cancer. 3)Previously treated with chemotherapeutic regimens including an anthracycline and a taxane first-line chemotherapy 4)Having evaluable disease according to RECIST 5)Prior chemotherapy 0-2 regimens for unresectable metastatic status 6)Having an adequate interval from prior therapy 1.chemotherapy:21days 2.endocrine therapy:7days 3.radiation therapy:14days 4.major surgery:28days 5.minor surgery:14days 6)PS (ECOG) 0-2 7)Eligible patient for eribulin therapy 8)Peripheral neuropathy G1 or G0(experienced peripheral neuropathy caused from previous chemotherapy) 9)Adequate organ functions 1.neutrophil=>1000mm3 2.platelet count=>75000mm3 3.AST,ALT=<2.5 times ULN(<5.0 with liver metastasis) 4.total bilirubin=<1.5 times ULN serum creatinine=<1.5mg/dL 10)Female over 20 years old 11)Obtained written informed consent
Key exclusion criteria	1)Forbidden case to use eribulin 2)Serious bone marrow suppression 3)Allergy to component of eribulin 4)Pregnant or like be pregnant 5)Serious liver or renal disorder 6)Inadequate interval from prior therapy 7)Symptomatic brain metastasis 8)Patient with CNS disease, DM, RA, or bone metastasis (possible involvement peripheral neropathy) 9)Peripheral neuropathy caused from surgery 10)With doctors decision for exclusion
Target sample size	48

Research contact person
Name of lead principal investigator	Morihito Okada
Organization	Hiroshima Unversity Hospital
Division name	Department of surgical oncology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5869
Email	morihito1217@gmail.com

Public contact
Name of contact person	Hideo Shigematsu
Organization	Hiroshima Unversity Hospital
Division name	Department of surgical oncology
Address	1-2-3 Kasumi, Minami-ku, Hiroshima
TEL	082-257-5869
Homepage URL
Email	shsasada@hiroshima-u.ac.jp

Sponsor
Institute	Dept of surgical oncology, Hiroshima university hospital
Institute
Department

Funding Source
Organization	Dept of surgical oncology, Hiroshima university hospital
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 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 01 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 01 Month 31 Day
Date trial data considered complete	2019 Year 02 Month 08 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2012 Year 08 Month 30 Day
Last modified on	2019 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010284