UMIN-CTR Clinical Trial

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