UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	"Adjuvant Chemotherapy Trial of S-1 for breast cancer with ER-positive and HER2-negative" Pharmacodynamics, Pharmacokinetics and Pharmacogenomics study
Title of the study (Brief title)	"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	Hiroshi Ishiguro
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Target Therapy Oncology
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	Hiroshi Ishiguro
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Target Therapy Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000007326