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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021585
Receipt No. R000024896
Scientific Title A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancer
Date of disclosure of the study information 2016/03/23
Last modified on 2018/12/18

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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
Middle name
Last name Kenichi Inoue
Organization Saitama Cancer Center
Division name Division of Breast Oncology
Zip code
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
Middle name
Last name Jun Ninomiya
Organization Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Division name Secretariat Division (Ninomiya hospital)
Zip code
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
Address
Tel
Email

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
2018 Year 12 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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