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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039606
Receipt No. 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

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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
Email 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
Email masahiro@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Breast Surgery, Graduate school of medicine, Kyoto University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045170

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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