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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006194
Receipt No. R000007326
Scientific Title "Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative" Pharmacodynamics, Pharmacokinetics and Pharmacogenomics study
Date of disclosure of the study information 2011/12/01
Last modified on 2017/08/22

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Basic information
Public title "Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative" Pharmacodynamics, Pharmacokinetics and Pharmacogenomics study
Acronym "Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative" Pharmacodynamics, Pharmacokinetics and Pharmacogenomics study
Scientific Title "Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative" Pharmacodynamics, Pharmacokinetics and Pharmacogenomics study
Scientific Title:Acronym "Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative" Pharmacodynamics, Pharmacokinetics and Pharmacogenomics study
Region
Japan

Condition
Condition Female patient with invasive breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Development of biological optimal dosing for S-1 from clinical pharmacology aspect
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics of S-1
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Blood and urine collection for pharmacokinetics analysis
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 who enrolled in "Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative"
Key exclusion criteria None
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ishiguro
Organization Graduate School of Medicine Kyoto University
Division name Department of Target Therapy Oncology
Zip code
Address 54 Shogoinkawahara-machi, Sakyo-ku, Kyoto-city
TEL 075-751-4950
Email hkkishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Ishiguro
Organization Graduate School of Medicine Kyoto University
Division name Department of Target Therapy Oncology
Zip code
Address 54 Shogoinkawahara-machi, Sakyo-ku, Kyoto-city
TEL 075-751-4950
Homepage URL
Email hkkishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine Kyoto University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 G-431
Org. issuing International ID_1 Kyoto University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 12 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 Completed
Date of protocol fixation
2011 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 06 Day
Last follow-up date
2020 Year 05 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 08 Month 18 Day
Last modified on
2017 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007326

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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