UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer
Acronym	SBCCSG-36
Scientific Title	A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer
Scientific Title:Acronym	SBCCSG-36
Region	Japan

Condition
Condition	First-Line therapy for metastatic 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 the usefulness of eribulin in combination with trastuzumab and pertuzumab as first line therapy for patients with metastatic HER2-positive breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	time to chemotherapy treatment failure of response rate
Key secondary outcomes	time to chemotherapy treatment failure, progression free survival, response rate, 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	Uncontrolled
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,trastuzumab, and pertuzumab every three weeks until disease progression or occurring adverse events difficult to continue.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1.Histologically confirmed primary breast cancer 2.Age of 18 years and expected survival is more than 6months 3.Histologically confirmed HER2-positive breast cancer in primary lesion or metastatic lesion(Score 3+ by IHC or HER2 Positive by FISH or DISH) 4.First line therapy of Stage IIIB,IIIC,IV or recurrent breast cancer 5.ECOG performance status(PS) 0 or 1(Allow PS 2 due to bone metastases) 6.Clinically confirmed measurable or unmeasurable metastatic lesion except ascites or effusion alone 7.Adequate organ function shown in physical examinations within 14 days prior to enrollment Neutrophil count >=1500/mm3 Platelet count >=75,000/mm3 Hemoglobin >=9.0g/dL Total serum bilirubin <=2.0mg/dL AST and ALT <100IU/L Serum creatinine <=1.5mg/dL 8.No clinical electrocardiographic abnormality 9.Echocardiographic ejection fraction >=55% 10.Subjects who have submitted written informed consent for study entry
Key exclusion criteria	1.Active infection or fever at risk of infection 2.History of serious drug allergies 3.Spontanous serious renal damage or liver dysfunction(jaundice) 4.Large pleural effusion or ascites requiring repeat drainage 5.Systemic administration of steroid drug 6.Pregnant females or females of child-bearing potential 7.Concurrent active other malignancy 8.Metachronous or spontaneous bilateral breast cancer except ductal carcinoma in situ 9.Clinically important mental disorder or history of central nervous system damage 10.Clinically significant central nervous system metastases 11.Concurrent enrollment of other clinical trial 12.Reccurence in conserving breast or local recurrence that is appropriate therapy to reoperate 13.HBs antigen positive 14.Not suitable for participation with any other reasons (including rapid progression disease, life threatening status if not successfully treated)
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Inoue
Organization	Saitama Cancer Center
Division name	Division of Breast Oncology
Zip code	3620806
Address	780, Komuro, Ina-machi, Kita-Adachi-gun, Saitama, Japan
TEL	048-722-1111
Email	ino@cancer-c.pref.saitama.jp

Public contact
Name of contact person	1st name Jun Middle name Last name Ninomiya
Organization	Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Secretariat Division (Ninomiya hospital)
Zip code	330-0843
Address	491-6 shineicho, soka-shi, saitama-shi
TEL	048-941-2223
Homepage URL	http://www.sbccsg.org/
Email	jninomiya@grape.plala.or.jp

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

Funding Source
Organization	Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Cancer Center
Address	780 komura ina kitaadachi Saitama Japan
Tel	0487221111
Email	sccctmo01@cancer-c.pref.saitama.jp

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	2016 Year 03 Month 23 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	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date	2016 Year 03 Month 24 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	2016 Year 03 Month 23 Day
Last modified on	2021 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024896