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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002632
Receipt No. R000003207
Scientific Title Clinical pharmacology study of anti-estrogen based on pharmacogenomics and pharmacokinetics for hormone-sensitive breast cancer patients (JBCRG-15)
Date of disclosure of the study information 2009/11/01
Last modified on 2019/09/05

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Basic information
Public title Clinical pharmacology study of anti-estrogen based on pharmacogenomics and pharmacokinetics for hormone-sensitive breast cancer patients (JBCRG-15)
Acronym JBCRG-15
(PGx-PK based clinical pharmacology study of anti-estrogen)
Scientific Title Clinical pharmacology study of anti-estrogen based on pharmacogenomics and pharmacokinetics for hormone-sensitive breast cancer patients (JBCRG-15)
Scientific Title:Acronym JBCRG-15
(PGx-PK based clinical pharmacology study of anti-estrogen)
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 difference in toremifen metabolite concentration between 40mg and 120mg in patients who are poor metaboliser for tamoxifen
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in toremifen metabolite concentration between 40mg and 120mg
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 Toremifen 40mg PO
Dose escaration to 120mg
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Histologycally proven breast cancer
On tamoxifen
Reduced tamoxifen activity
Able to take toremifen at least 3 months
ECOG PS 0~2
20 to 70years old
Adequite organ function
Written IC obtained
Key exclusion criteria History of thromboembolism
Clinically significant myoma uteri
Requiring CYP3A4 inhibitor
Clinically significant co-morbidity
Pregnant or its posibility
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Ishiguro
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code 606-8507
Address 54 Syogoinkawahara-cho, Sakyo-ku, Kyoto-city
TEL 075-751-4771
Email hishimd@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Ishiguro
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code 606-8507
Address 54 Syogoinkawahara-cho, Sakyo-ku, Kyoto-city
TEL 075-751-4771
Homepage URL
Email hishimd@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
Name of secondary funder(s)

IRB Contact (For public release)
Organization N/A
Address N/A
Tel N/A
Email N/A

Secondary IDs
Secondary IDs YES
Study ID_1 C-351
Org. issuing International ID_1 Kyoto University Hospital
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)
九州がんセンター(福岡県)
兵庫県立がんセンター(兵庫県)
群馬県立がんセンター(群馬県)
広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 01 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 273
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Additional publication is awaiting.
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 10 Month 14 Day
Date of IRB
2009 Year 11 Month 18 Day
Anticipated trial start date
2010 Year 10 Month 07 Day
Last follow-up date
2015 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 15 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003207

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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