UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008859 |
|---|---|
| Receipt number | R000010401 |
| Scientific Title | Phase I/II study with GEM/TS-1 combination for metastatic breast cancer (KSCOG BC-03) |
| Date of disclosure of the study information | 2012/09/08 |
| Last modified on | 2019/01/08 18:35:29 |
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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
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
Iwakuma@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Faculty of Medicine
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
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
Value
https://center6.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 |
