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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006383
Receipt No. R000007574
Scientific Title Phase I and dose-finding study of TS-1 with Abraxane for metastatic breast cancer
Date of disclosure of the study information 2011/09/26
Last modified on 2011/09/21

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Basic information
Public title Phase I and dose-finding study of TS-1 with Abraxane for metastatic breast cancer
Acronym TS-1/ABI Phase I tudy
Scientific Title Phase I and dose-finding study of TS-1 with Abraxane for metastatic breast cancer
Scientific Title:Acronym TS-1/ABI Phase I tudy
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

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/day day1 through 14
Abraxane:180mg/m2-260mg/m2/day 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
75 years-old >
Gender Female
Key inclusion criteria 1)histologically confirmed breast cancer
2)age more than 20 and below 75
3)PS(ECOG)0-1
4)survival period more than 6 months
5)no effect remain from prior chemotherapy
6)adequate organ function
WBC>=4,000/mm3 and <=12,000/mm3
NEU>=2,000/mm3
PLT>=100,000/mm3
Hb>=9.0g/dl
Cr<=2.0 times of nomal range in institute
Ccr>=50ml/min
sT-Bil<=1.5mg/dl
AST/ALT<=2.0 times of nomal range in institute
7)written informed consent
Key exclusion criteria 1)male breast cancer
2)taboo to use TS-1 or Abraxane
3)had undergone treatment with TS-1 or Abraxane chemotherapy prior to this study
4)pregnant or nursing women or who like be pregnant.possible to pregnancy
5)with active double cancer
6)wiht severe complications
7)uncontrolled dropsy pleural effusion,abdominal dropsy
8)wiht brain metastasis
9)had a previos serious medical illness or allergy
10)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 Akira Tangoku
Organization Tokushima University Hospital
Division name Depertment of esophageal, Breast and thyroid diseases
Zip code
Address Kuramoto 2-50-1 tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima University Hospital
Division name Depertment of esophageal, Breast and thyroid diseases
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Tokusima University Hospital
Institute
Department

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
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
2011 Year 09 Month 26 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 Preinitiation
Date of protocol fixation
2011 Year 08 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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
2011 Year 09 Month 21 Day
Last modified on
2011 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007574

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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