UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039606 |
|---|---|
| Receipt number | R000045170 |
| Scientific Title | Follow up study of adjuvant chemotherapy trial of S-1 for breast cancer with ER-positive and HER2-negative |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/02/26 16:01:22 |
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Basic information
Public title
Follow up study of adjuvant chemotherapy trial of S-1 for breast cancer with ER-positive and HER2-negative
Acronym
Follow up study of the POTENT trial
Scientific Title
Follow up study of adjuvant chemotherapy trial of S-1 for breast cancer with ER-positive and HER2-negative
Scientific Title:Acronym
Follow up study of the POTENT trial
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the survival and information about subsequent treatment after the POTENT trial
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Disease-free survival, Cause of death, Site of recurrence, Treatment for recurrence, incidence of secondary cancer, treatment for secondary cancer
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
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients included in POTENT trial (UMIN000003969)
Key exclusion criteria
Patients excluded from POTENT trial (UMIN000003969)
Target sample size
1930
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Toi |
Organization
Graduate school of medicine, Kyoto University
Division name
Breast Surgery
Zip code
606-8507
Address
54, Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
toi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Takada |
Organization
Kyoto University Hospital
Division name
Breast Surgery
Zip code
606-8507
Address
54, Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3660
Homepage URL
masahiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Breast Surgery, Graduate school of medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Taiho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2020 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the survival and information about subsequent treatment after the POTENT trial
Management information
Registered date
| 2020 | Year | 02 | Month | 26 | Day |
Last modified on
| 2020 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045170
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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