UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the efficacy of Eribulin retreatment in HER2 negative Metastatic Breast Cancer patients - Phase II study -
Title of the study (Brief title)	Evaluation of Eribulin retreatment - Phase II study -
Region	Japan

Condition
Condition	HER2-negative metastatic breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy and safety for Eribulin retreatment in HER2 negative Metastatic Breast Cancer patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Progression Free Survival(retreatment of Eribulin)
Key secondary outcomes	Objective Response Rate and Safety

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	To reintroduce Eribulin for Metastatic Breast Cancer patients who received prior Eribulin treatment and had effect
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	75 years-old >=
Gender	Female
Key inclusion criteria	1,Pathologically confirmed primary breast cancer 2,Inoperable or recurrent breast cancer 3,HER2-negative by IHC or FISH 4,ECOG performance status 0-2 at the registration 5,Metastatic Breast Cancer patients who received prior Eribulin treatment and had effect(SD or more) 6,Patients at least 1 year after prior Eribulin treatment 7,Patients with measurable lesions 8,Patients in whom the major organ functions have been maintained (The criteria listed below are all met within 14 days before enrollment) Neutrophil count: At least 1,500/mm3 Platelet count: At least 75,000 mm3 Hemoglobin: At least 8.0 g/dL Total bilirubin: Not exceeding 2.0 mg/dL AST and ALT: Under 100 IU/L(Under 300 IU/L for patients who has hepatic metastasis) 9,Age of 20-75 years 10,Duration of survival is expected more than 3 months 11,Patients from whom written consent for participation in the study has been obtained in person
Key exclusion criteria	1.Patient with active infection 2.Pregnant, lactating, or intends to become pregnant 3.brain metastasis with clinical symptoms 4.Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	30

Research contact person
Name of lead principal investigator	Hideaki Ogata
Organization	Toho University Omori Medical Center
Division name	Breast and Endocrine Surgery
Address	6-11-1, Omori-Nishi Ota-ku, Tokyo , Japan
TEL	0337624151
Email	ogatah@med.toho-u.ac.jp

Public contact
Name of contact person	Fumi Saito
Organization	Toho University Omori Medical Center
Division name	Breast and Endocrine Surgery
Address	6-11-1, Omori-Nishi Ota-ku, Tokyo , Japan
TEL	0337624151
Homepage URL
Email	fumi.saitou@med.toho-u.ac.jp

Sponsor
Institute	Toho university
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2017 Year 05 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 01 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	2017 Year 04 Month 27 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031130