UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Title of the study (Brief title)	Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Region	Japan

Condition
Condition	Advanced/recurrent HER2-positive breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate Efficacy and Safety the combination of Eribulin and Trastuzumab in Patients with advanced/recurrent HER2-positive breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Objective Response Rate
Key secondary outcomes	Clinical Benefit Rate Overall Survival Progression Free Survival Time to Treament Failure 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	Eribulin 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. Administration trasutuzumab every 3week with a starting dose of 8mg/kg followed by 6mg/kg as the second and subsequent doses.
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)female patient who were histologically confirmed as breast cancer 2)previously treated with combination chemotherapeutic and anti-HER2 therapy 3)aged more than 20years and less than 75 years 4)ECOG PS of 0-2 5)having measurable lesion according to RECIST 6)adequate organ functions confirmed with following major examination: neutrophil count more than 1500/microL platelet count more than 100,000/microL hemoglobin more than 8.0g/dL AST,ALT less than 2.5 times the upper limit of nomal (ULN) AST,ALT of the patient with the metastasis to liver less than 5.0 times the upper limit of nomal (ULN) total bilirubin less than 1.5 times the upper limit of nomal (ULN) serum creatinine less than 1.5 times the upper llimit of nomal (ULN) 7)obtained written informed consent
Key exclusion criteria	1)having systemic infection with a fever of 38 degrees or more 2)pleural effusion, ascites, or pericardial fluid requiring drainage 3)brain metastasis with clinical symptoms 4)patient with following serious complication ischaemic heart disease or heart disease such as arrhythmia not controllable by treatment myocardial infarction < 6 months prior to study entry hepatic cirrhosis interstitial pneumonia or pulmonary fibrosis bleeding tendency 5)having active double cancer 6)HER2 over-expressed 7)pregnancy, breast-feeding or women with childbearing potential 8)judged by the investigator not to be appropriate for the study
Target sample size	35

Research contact person
Name of lead principal investigator	Tsuyoshi Saito
Organization	Saitama Red Cross Hospital
Division name	Department of breast surgery
Address	8-3-33, Kamiochiai, Cyuo-ku, Saitama-city, Japan
TEL	048-852-1111
Email	tsaito@jcom.home.ne.jp

Public contact
Name of contact person	Toshihiro Kai
Organization	Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' Mammo Clinic)
Address	3F Capital Building ,4-261-1 kishiki-cho, omiya-ku, saitama-shi
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	Sairtama Breast Cancer Clinical Study Group (SBCCSG)na
Institute
Department

Funding Source
Organization	none
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	さいたま赤十字病院，埼玉県立がんセンター，埼玉社会保険病院，自治医大さいたま医療センター，赤心堂病院

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 05 Month 08 Day
Anticipated trial start date	2013 Year 06 Month 24 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	2013 Year 06 Month 23 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012902