UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The exploratory study for the drug-predictive markers of TS-1 in metastatic or recurrent breast cancer; Translational biomarker study of SELECT BC trial
Title of the study (Brief title)	SELECT BC - the better drug predictive marker analysis (SELECT BC-EURECA)
Region	Japan

Condition
Condition	Metastatic or recurrent breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To find the predictive biomarkers of TS-1 for the breast cancer based on expression of mRNA related with 5-FU metabolism using samples from patients who participated in SELECT BC trial
Basic objectives2	Others
Basic objectives -Others	Transralational research for predictive biomarker of TS-1
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between the bio-marker and clinical efficacy, i.e. PFS: progression free survival, of each patient who has participated in SELECT BC trial
Key secondary outcomes	Correlation between the bio-marker and clinical efficacy, i.e. TTF:Time to Treatment Failure, OS:Overall survival, and DCR:Disease control rate, of each patient who has participated in SELECT BC trial

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	1) Institutional review board (IRB) approval for research and transportation of breast cancer samples 2) Availability to obtain surgical specimen or core needle biopsy sample of breast cancer
Key exclusion criteria	1) Patients not adequate for participation in this study at doctors' discretion. 2) Patients not obtained informed consentnot obtained informed consent
Target sample size	140

Research contact person
Name of lead principal investigator	Fumikata Hara
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of breast oncology
Address	160 Kou, Minamiumemoto-chou, Matsuyama
TEL	089-999-1111
Email	hfumikat@shikoku-cc.go.jp

Public contact
Name of contact person	Akira Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Oncology Research
Address	1-1-7, Nishiwaseda, Shinjyuku-ku Tokyo,
TEL	03-5287-2636
Homepage URL	http://www.csp.or.jp/
Email	support@csp.or.jp

Sponsor
Institute	SELECT BC executive committee
Institute
Department

Funding Source
Organization	Public Health Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	2014 Year 06 Month 12 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 02 Month 10 Day
Anticipated trial start date	2014 Year 02 Month 10 Day
Last follow-up date	2015 Year 12 Month 31 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	Not applicable

Management information
Registered date	2014 Year 06 Month 12 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016594