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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018758
Receipt No. R000021696
Scientific Title The additional biomarker study and clinical outcome of Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer.
Date of disclosure of the study information 2015/08/24
Last modified on 2019/08/24

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Basic information
Public title The additional biomarker study and clinical outcome of Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer.
Acronym The additional study of a phase II study of Neoadjuvant Eribulin in TNBC patients
Scientific Title The additional biomarker study and clinical outcome of Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer.
Scientific Title:Acronym The additional study of a phase II study of Neoadjuvant Eribulin in TNBC patients
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Medicine in general Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. Analyze the biomarker of neo-adjuvant Eribulin therapy in a patient with breast cancer and investigate the relationship between biomarker and clinical outcome.
2. Conduct a long term follow-up both overall survival and relapse free survival of the patients in Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical outcome(Survival, relapse)
Biomarkers
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Female
Key inclusion criteria 1. The patients who perticipate with Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer.
2. A patient who gives written informed consent.
Key exclusion criteria Patient considered irrelevant by attending physician for the study
Target sample size 43

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Tamura
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email ketamura@ncc.go.jp

Public contact
Name of contact person
1st name Noguchi
Middle name
Last name Emi
Organization National Cancer Center Hospital
Division name Breast and Medical Oncology
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email enoguchi@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Cancer Center Hospital
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email irst@ml.res.ncc.go.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
2015 Year 08 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 No longer recruiting
Date of protocol fixation
2015 Year 01 Month 13 Day
Date of IRB
2015 Year 03 Month 10 Day
Anticipated trial start date
2015 Year 03 Month 10 Day
Last follow-up date
2022 Year 03 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information four years follow up after last patient in and one year follow up of the patient
Biomarker study of UMIN000014163

Management information
Registered date
2015 Year 08 Month 21 Day
Last modified on
2019 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021696

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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