UMIN-CTR Clinical Trial

Basic information
Public title	Phase I/II study with GEM/TS-1 combination for metastatic breast cancer (KSCOG BC-03)
Acronym	Phase I/II study with GEM/TS-1 combination for metastatic breast cancer (KSCOG BC-03)
Scientific Title	Phase I/II study with GEM/TS-1 combination for metastatic breast cancer (KSCOG BC-03)
Scientific Title:Acronym	Phase I/II study with GEM/TS-1 combination for metastatic breast cancer (KSCOG BC-03)
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of GEM/TS-1 in patients with metastatic breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Response rate
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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Chemotherapy
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	Not applicable
Gender	Female
Key inclusion criteria	1.histologically confirmed breast cancer 2.age more than 20 3.PS(ECOG)0-1 4.survival period more than 6 months 5.more than 1 months passed after chemotherapy 6.adequate organ function 1)WBC>=3,000/mm3 and <=12,000/mm3 2)NEU>=2,000/mm3 3)PLT>=100,000/mm3 4)Hb>=9.0g/dl 5)Cr<=1.5 times of normal range in institute 6)Ccr>=60ml/min 7)sT-Bil<=1.5mg/dl 8)AST/ALT<=2.0 times of normal range in institute 9)written informed consent
Key exclusion criteria	1.Non-invasive cancer or micro-invasive cancer 2. taboo to use Gemcitabine or TS-1 3. male breast cancer 4.pregnant or nursing women or who suspected pregnant 5.with active double cancer 6.with severe complications 7.had a previous cardiac dysfunction or having cardiac dysfunction 8.uncontrolled edema 9.had a previous serious medical illness or allergy 10.doctor's decision not to be registered to this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toh Uhi
Organization	Kurume University Faculty of Medicine
Division name	Department of Surgery
Zip code
Address	67 Asahi-machi, Kurume, Fukuoka
TEL	0942-31-7655
Email	utoh@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Iwakuma Nobutaka
Organization	same as above
Division name	same as above
Zip code
Address	same as above
TEL	0942-31-7566
Homepage URL
Email	Iwakuma@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University Faculty of Medicine
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	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	2012 Year 09 Month 08 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	Terminated
Date of protocol fixation	2012 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 09 Month 05 Day
Last modified on	2019 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010401

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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