UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016377 |
|---|---|
| Receipt number | R000019017 |
| Scientific Title | Phase 1 study of TS-1 with Abraxane for metastatic breast cancer |
| Date of disclosure of the study information | 2015/01/30 |
| Last modified on | 2015/07/29 13:29:06 |
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Basic information
Public title
Phase 1 study of TS-1 with Abraxane for metastatic breast cancer
Acronym
TS-1/ABI Phase 1 study
Scientific Title
Phase 1 study of TS-1 with Abraxane for metastatic breast cancer
Scientific Title:Acronym
TS-1/ABI Phase 1 study
Region
| Japan |
Condition
Condition
metastatic breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate maximum tolarated doze and recommended dose of TS-1 and Abraxane combination chemotherapy for metastatic breast cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To determinate maximum tolerated dose and recommended dose
Key secondary outcomes
Response rate,frequency and degree of side effect
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
TS-1:65mg/m2-80mg/m2
day1 through 14
Abraxane:180mg/m2-260mg/m2 day1
Cycles are repeated every 3 weeks
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1)histologically confirmed breast cancer
2)age more than 20 and below 65
3)PS(ECOG)0-1
4)survival period more than 6 months
5)no effect remain from prior chemotherapy
6)adequate organ function
WBC>=4000/mm3
Neu>=2000/mm3
Hb>=9.0g/dL
Plt>=100000/mm3
sT-Bil<=1.5mg/dL
AST<=100IU/L
ALT<=100IU/L
Cr>=60ml/min
7)written informed consent
Key exclusion criteria
1)had a previous allergy for TS-1 or Abraxane
2)be pregnant or possible to pregnancy
3)with active breast cancer
4)with severe complications
5)with uncontrolled pleural effusion,ascites and edema
6)with brain metastasis
7)doctor's decision not to be registered to this study
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tetsuya taguchi |
Organization
kyoto prefectural university of medicine
Division name
Dept of Endocrine and Breast surgery
Zip code
Address
465-kajii cho,kawaramachi-hirokoji,kamigyo-ku,kyoto-city,602-8566
TEL
075-251-5534
breast@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | katsuhiko nakatsukasa |
Organization
kyoto prefectural university of medicine
Division name
Dept of Endocrine and Breast surgery
Zip code
Address
465-kajii cho,kawaramachi-hirokoji,kamigyo-ku,kyoto-city,602-8566
TEL
075-251-5534
Homepage URL
kacchan@koto.kpu-m.ac.jp
Sponsor or person
Institute
kyoto prefectural university of medicine
Institute
Department
Personal name
Funding Source
Organization
kyoto prefectural university of medicine
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
| 2015 | Year | 01 | Month | 30 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 19 | 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
| 2015 | Year | 01 | Month | 29 | Day |
Last modified on
| 2015 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019017
