UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer
Title of the study (Brief title)	ERIS-Study
Region	Japan

Condition
Condition	Advanced and recurrent breast cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of eribulin/S-1 combination therapy for HER2 negative, advanced/recurrent breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall response rate
Key secondary outcomes	Safety, Duration of response, Progression free survival, Disease control rate, Clinical benefit rate, Overall survival, New metastasis-free survival

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Combination therapy of Eribulin and S-1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Female
Key inclusion criteria	1.histlogically or cytologically confirmed breast cancer 2.patients with unresectable stage 3C or 4 3.patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence. 4.HER2 negative 5.patients previously treated with no more than 2 chemotherapy regimen for recurrent/metastasis breast cancer 6.patients with more than one of the following (1)ER negative (<10%) (2)internal metastasis (3)more than 3 metastatic sites (4)DFI<= 2years 7.patients at least 20 years of age but not older than 75 at the time of informed 8.ECOG performance status 0-1 9.patients with evaluable lesion(identified within 28 days before the entry) by RECIST 1.1 criteria 10.Required baseline laboratory parameters (within 14 days before the entry) neutrophil >=1,500/mm3 Plt >=100,000/mm3 Hb >=9.0g/dL AST and ALT <=100IU/L, (AST and ALT<=150IU/L, if patients have liver metastasis) total bilirubin <=1.5mg/dL creatinine clearance <=60 ml/min 11.no carry-over effect or side effect that could affect the study outcome of prior treatment washout period; 1) >=4weeks: antibody-drug, chemotherapy,operative treatment 2) >=2weeks:radiotherapy, endocrine therapy, immunotherapy, oral fluoride pyrimidine-based drug, molecular target drug, blood transfusion, blood products, G-CSF 12.written informed consent was obtained 13.with life expectancy greater than 3 months.
Key exclusion criteria	1.patients with history of prior treatment with eribulin and S1 2.patients with infection or HBs antigen positive 3.pleural effusion, peritoneal effusion which needs drainage 4.brain metastasis with clinical symptoms 5.patients with following serious complication (1)ischemic heart disease and arrhythmic cardiac disease with poor control. (2)ischemic heart disease within 6 months, (3)liver cirrhosis, (4)watery diarrhea (5)interstitial pneumonia or pulmonary fibrosis by chest radiograph (6)bleeding tendency (7)another serious complication 6.patients with active double cancer 7.patients who need to receive continuous corticosteroid administration 8.patients with a history of widespread radiation therapy 9.pregnant or nursing women 10.patients with serious drug allergy 11.patients who are participating in the other clinical trial 12.patients judged improper to entry this trial by physician
Target sample size	32

Research contact person
Name of lead principal investigator	Junji Tsurutani
Organization	Kindai University Hospital, Faculty of medicine
Division name	Department of medical oncology
Address	377-2 Ohnohigashi, Osakasayama City, Osaka, Japan
TEL	072-366-0221
Email	tsurutani_j@dotd.med.kindai.ac.jp

Public contact
Name of contact person	Advanced Clinical Research Organization
Organization	Advanced Clinical Research Organization
Division name	ERIS STUDY OFFICE
Address	4F Hoei Fuchu Bulding,2-10-3 Kotobukicho, Fuchu-shi,Tokyo
TEL	042-352-7676
Homepage URL
Email	eris-study@npo-acro.jp

Sponsor
Institute	Advanced Clinical Research Organization
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Eisai
Organization
Division
Category of Funding Organization	Profit organization
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	2014 Year 09 Month 05 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 08 Month 12 Day
Anticipated trial start date	2014 Year 09 Month 05 Day
Last follow-up date	2017 Year 05 Month 31 Day
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	2014 Year 09 Month 04 Day
Last modified on	2016 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017483