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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001665
Receipt No. R000002013
Scientific Title Effect of drug metabolizing enzyme gene polymorphism on selective estrogen receptor modulator pharmacokinetics in breast cancer (JBCRG-12)
Date of disclosure of the study information 2009/02/01
Last modified on 2018/08/23

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Basic information
Public title Effect of drug metabolizing enzyme gene polymorphism on selective estrogen receptor modulator pharmacokinetics in breast cancer (JBCRG-12)
Acronym JBCRG-12
(Pharmacokinetics-pharmacogenomics study in breast cancer endocrine treatment)
Scientific Title Effect of drug metabolizing enzyme gene polymorphism on selective estrogen receptor modulator pharmacokinetics in breast cancer (JBCRG-12)
Scientific Title:Acronym JBCRG-12
(Pharmacokinetics-pharmacogenomics study in breast cancer endocrine treatment)
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Investigate the correlation between CYP2D6 gene polymorphism and pharmacokinetics of tamoxifen or toremifen. Correlations with adverse event or clinical efficacy will be analyzed, too.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes CYP2D6 gene polymorphism
Pharmacokinetics of tamoxifen and its active metabolites or toremifen and its active metabolites
Key secondary outcomes Adverse event
Drug efficacy

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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 Blood test
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Breast cancer patients who are taking either tamoxifen or toremifen
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ishiguro
Organization Graduate School of Medicine Kyoto University
Division name Department of Target Therapy Oncology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL 075-751-4950
Email hkkishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi ishiguro
Organization Graduate School of Medicine Kyoto University
Division name Department of Target Therapy Oncology
Zip code
Address 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan 606-8507
TEL 075-751-4950
Homepage URL
Email hkkishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute JBCRG(Japan Breast Cancer Research Group)
Institute
Department

Funding Source
Organization JBCRG(Japan Breast Cancer Research Group)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyoto University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JBCRG-12
Org. issuing International ID_1 Japan Breast Cancer Research Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都大学医学部附属病院(京都府)
群馬県立がんセンター(群馬県)
都立駒込病院(東京都)
兵庫県立がんセンター(兵庫県)
九州がんセンター(福岡県)
新潟県立がんセンター(新潟県)
筑波大学附属病院(茨城県)
広島大学病院(広島県)
熊本大学医学部附属病院(熊本県)
彦根市立病院(滋賀県)
愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2009 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 02 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
2009 Year 01 Month 28 Day
Last modified on
2018 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002013

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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