UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy for triple negative breast cancer(SBCCSG-14).
Title of the study (Brief title)	Feasibility study of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy for triple negative breast cancer(SBCCSG-14).
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the feasibility, safety and efficacy of S-1 as additional therapy after neo-adjuvant or adjuvant chemotherapy and radiotherapy that was carried out if necessary, for ER negative, PgR negative and HER2 negative breast cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Feasibility
Key secondary outcomes	Safety Overall survial Disease free survival Relative dose intensity Biomarkers

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 80mg/m2 b.i.d., day1-14 q3w, 1 yr
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	70 years-old >=
Gender	Female
Key inclusion criteria	1) Histologically confirmed primary breast cancer. 2) ER(-), PgR(-) and HER2(-) 3) Received primary systemic therapy. 4) Age more than 20years and less than 75 years. 5) ECOG performance status of 0 or 1. 6) Possible to take orally 7) Required baseline laboratory parameters (within 14 days before registration): WBC more than 4000 /mm3 Neu more than 2000 / mm3 Plt more than 100,000/mm3 Hb more than 9.0g/dl AST less than 2.5 times ULN ALT less than 2.5 times ULN T-Bil less than 1.5mg/dl Cre less than 1.2mg/dl Ccr more than 60ml/min 8) Signed informed consent of the patient for the registration.
Key exclusion criteria	1) Either of ER, PgR, HER2 is positive by surgical specimen. 2) Male breast cancer 3) Severe complications (uncontrolled diabetes mellitus, infection, heart failure which needs medical treatment (unstable angina pectoris, history of myocardial infarction occurred within 6 months), mental disorder) 4) Interstitial lung disease, pulmonary fibrosis 5) History of serious drug allergy 6) Active other malignancies 7) During pregnancy or lactation 8) History of hypersensitivity 9) History of serious hypersensitivity to fluoropyrimidines 10) During administration of fluoropyrimidines 11) During administration of flucytosine 12) Patients judged inappropriate by physicians
Target sample size	60

Research contact person
Name of lead principal investigator	Toshio Tabei
Organization	Saitama Cancer Center
Division name	Breast Medical Oncology
Address	818 Ina-machi oaza komuro, Kita-adachi-gun, Saitama, 362-0806, Japan
TEL	048-722-1111
Email	ino@cancer-c.pref.saitama.jp

Public contact
Name of contact person	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group(SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' MammoClinic)
Address	3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	toshikai@sbccsg.org

Sponsor
Institute	Saitama Breast Cancer Clinical Study Group(SBCCSG)
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	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	2008 Year 10 Month 06 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2008 Year 06 Month 18 Day
Anticipated trial start date	2008 Year 10 Month 01 Day
Last follow-up date	2015 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2008 Year 10 Month 05 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001719