UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002064 |
|---|---|
| Receipt number | R000002516 |
| Scientific Title | A phaseI/II study of TS-1 and Docetaxel with Metastatic Breast Cancer patients resisting for Docetaxel |
| Date of disclosure of the study information | 2009/06/11 |
| Last modified on | 2011/12/10 09:12:09 |
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Basic information
Public title
A phaseI/II study of TS-1 and Docetaxel with Metastatic Breast Cancer patients resisting for Docetaxel
Acronym
A phaseI/II study of TS-1 and Docetaxel with Metastatic Breast Cancer patients resisting for Docetaxel (TABRET)
Scientific Title
A phaseI/II study of TS-1 and Docetaxel with Metastatic Breast Cancer patients resisting for Docetaxel
Scientific Title:Acronym
A phaseI/II study of TS-1 and Docetaxel with Metastatic Breast Cancer patients resisting for Docetaxel (TABRET)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effectiveness of TS-1 + Taxotere compared to Docetaxel alone with Taxotere resisting metastatic Breast Cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Decide most tolerable dose and
recommend dose of medicine
Phase II: Response rate
Key secondary outcomes
Phase I: Adverse events
Phase II: Disease free survival time, all survival time and adverse
events
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Phase I
TS-1 is administered orally on days
1-14 and stop on days 15-28.
This schedule is one course.
Taxotere is injected by vein on day1
and 15. The dose level is below.
Level 0 30mg/m2
Level 1 40mg/m2
Level 2 50mg/m2
Level 3 60mg/m2
3-6 patients will be enrolled at
each level
Interventions/Control_2
Phase II
Recommended dose of TS-1/Taxotere is used with 25 breast cancer patients
involving who recommended level patients in phase I.
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) Histologically confirmed breast cancer patients
2) Brest cancer patients not performed curative resection
3) Breast cancer patients receiving with TXT therapy and are diagnosed as SD by diagnostic image
4) More than 20 years old and less 75 years old
5) Performance status(ECOG) shows from 0 to one
6) Expected survival time more than
3 months at least
7) Measurable region can be diagnosed
by RECIST
8) Not received by 5-FU derivatives
9) Adequate organ functions
10) Written informed consent
Key exclusion criteria
1) Concomitant malignancy
2) Patient with contraindicate TS-1 and TXT
3) Complications including severe heart disease
4) Patient with cardiac infarction within 6 months
5) Serious renal function disturbance
6) Patient with cirrhosis
7) Patient with dyspnea by pheumonitis and lung fibrosis
8) Patient with uncontrolled diabetia
9) Patient with infectious
10)Gravida and having will of pregnancy
11) Patient with chemical allergy
12) Unsuitable patients by doctors diagnosis
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Tanaka |
Organization
Kawasaki Medical School
Division name
Breast and Thyroid Surgery
Zip code
Address
577,Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Tanaka |
Organization
Kawasaki Medical School
Division name
Breast and Thyroid Surgery
Zip code
Address
577,Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
tanakaka@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Breast and Thyroid Surgery, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
| 2009 | Year | 06 | Month | 11 | 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
no registry
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
| 2008 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 10 | Day |
Last modified on
| 2011 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002516
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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