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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002064
Receipt No. 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

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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
Email

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
Email tanakaka@med.kawasaki-m.ac.jp

Sponsor
Institute Department of Breast and Thyroid Surgery, Kawasaki Medical School
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002516

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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