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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011020
Receipt No. R000012902
Scientific Title Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Date of disclosure of the study information 2013/06/24
Last modified on 2017/11/30

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Basic information
Public title Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Acronym Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Scientific Title Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.
Scientific Title:Acronym 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
1st name
Middle name
Last name Tsuyoshi Saito
Organization Saitama Red Cross Hospital
Division name Department of breast surgery
Zip code
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
1st name
Middle name
Last name Toshihiro Kai
Organization Sairtama Breast Cancer Clinical Study Group (SBCCSG)
Division name Secretariat Division (Shintoshin Ladies' Mammo Clinic)
Zip code
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)

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 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

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 Enrolling by invitation
Date of protocol fixation
2013 Year 05 Month 08 Day
Date of IRB
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

Other
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

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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