UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002632 |
|---|---|
| Receipt number | 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 | 2021/08/13 16:09:25 |
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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
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
hishimd@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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
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
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
14
Results
TOR activity increased significantly with dose escalation, even among poor TAM metabolizers, and was maintained for >=24 weeks. TOR might be a valid alternative to TAM in patients predicted to be poor TAM metabolizers.
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
Among the 14 patients enrolled, 12 patients completed the PK study.
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 | 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
| 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=R000003207
| 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 |
