UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018758 |
|---|---|
| Receipt number | 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 | 2023/08/27 09:47:40 |
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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
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
enoguchi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 03 | Month | 09 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 09 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Biomarker study with 4-year follow-up of patients who participated in the UMIN000014163 clinical trial and 1-year follow-up of patients
Management information
Registered date
| 2015 | Year | 08 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021696
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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