UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006194 |
|---|---|
| Receipt number | 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 09:04:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hkkishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007326
