UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001665 |
|---|---|
| Receipt number | 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 | 2021/08/13 16:07:54 |
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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 | Hiroshi |
| Middle name | |
| Last name | Ishiguro |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Target Therapy Oncology
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-4950
hkkishi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ishiguro |
Organization
Graduate School of Medicine Kyoto University
Division name
Department of Target Therapy Oncology
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-4950
Homepage URL
https://www.jbcrg.jp/
hkkishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
JBCRG(Japan Breast Cancer Research Group)
Institute
Department
Personal name
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
JBCRG
Address
9-4 Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
Tel
03-6264-8873
office@jbcrg.jp
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
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs12282-019-00952-9
Number of participants that the trial has enrolled
273
Results
The CYP2D6 genotype was the major determinant for TAM activity (p < 0.01). Smoking status (p = 0.07) and the CYP2C19 phenotype (p = 0.07), but not the CYP2D6 genotype (p = 0.61), showed marginally significant effects on TOR activity.
Results date posted
| 2021 | Year | 08 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 02 | Month | 07 | Day |
Baseline Characteristics
Age (Median): 50years old
Weight (Median): 52.9kg
History of smoking+: 5.5%
Anti-estrogen used
TAM 20mg 66.7%
TOR40mg 22.3mg
TOR 120mg 11.0%
CYP inhibitor use
2D6 inhibitor: 1.1%
3A4 inhibitor: 4.4%
both: 5.1%
none: 89.5%
Participant flow
Breast cancer patients taking either TAM or TOR were enrolled.
Pharmacogenomics (PGx) analysis for CYP2D6, CYP2C19, and ABCC2 (MRP2) was conducted.
Adverse events
Hot flush
Grade 1: 29.7%
Grade 2: 9.9%
Grade 3: 0.4%
Outcome measures
Polymorphism of CYP2D6, CYP2C19 and ABCC2
Pharmacokinetics of TAM and TOR
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
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002013
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
