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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006965
Receipt No. R000008225
Scientific Title Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Date of disclosure of the study information 2012/01/04
Last modified on 2017/11/30

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Basic information
Public title Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Acronym Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Scientific Title Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Scientific Title:Acronym Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who presented well-defined taxane resistance
Region
Japan

Condition
Condition 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 of Eribulin in patients with Taxane-resisted Metastatic breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Clinical Benefit Rate
Key secondary outcomes EORTC QLQ-C30
Progression Free Survival
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 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
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 or cytologically confirmed as breast cancer
2)previously treated with chemotherapeutic regimens including an anthracycline and a taxane:
relapse during or within a year after neoadjuvant or post-operative adjuvant chemothrapy
with a taxane immediately before the study
progression during chemothrapy with a taxane in the metastatic setting
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)
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 52

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 Toshihiro Kai
Organization Saitama 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 Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

Funding Source
Organization Saitama Breast Cancer Clinical Study Group (SBCCSG)
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 埼玉県立がんセンター,さいたま赤十字病院,自治医大さいたま医療センター,埼玉社会保険病院,赤心堂病院,春日部市立病院

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 04 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 Completed
Date of protocol fixation
2011 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2016 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 12 Month 27 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=R000008225

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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