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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016377
Receipt No. 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

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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
Email 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
Email kacchan@koto.kpu-m.ac.jp

Sponsor
Institute kyoto prefectural university of medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019017

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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