UMIN-CTR Clinical Trial

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