UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004294 |
|---|---|
| Receipt number | R000005149 |
| Scientific Title | Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients |
| Date of disclosure of the study information | 2010/09/30 |
| Last modified on | 2018/10/10 12:52:30 |
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Basic information
Public title
Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients
Acronym
Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients
Scientific Title
Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients
Scientific Title:Acronym
Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients
Region
| Japan |
Condition
Condition
premenopausal breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Endocrine hormone markers
Key secondary outcomes
Lipid markers,Bone markers,Safety,DFS,OS
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
40mg of toremifene daily p.o for 5 years. 11.25mg of leuprolide acetate every 3 months.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1.Stage I-IIIA Breast cancer diagnosed histologically with a breast removed or preserved. aged 20 years or more
2.Positive ER or PR testing by immunohistochemistry (IHC), enzyme immunoassay (EIA) and who meet the criteria of each institution.
3. HER2 negative by IHC or FISH
4.Patient Status (PS): 0 or 1.
5.Fully functional heart, liver, kidneys, and bone marrow.
6.Less than one year since last menstruation under 60 years old or tested premenopausal from estradiol (E2) and follicle-stimulating hormone (FSH) levels.
7.Expected to live for at least three months (or longer) after study commencement.
8.Written consent obtained for study participation.
Key exclusion criteria
1.Previous treatment for the breast cancer.
2.Inflammatory breast cancer or bilateral breast cancer.
3.Bilateral breast cancer
4.Active other malignancies
5.Past history of drug allergy or hypersensitivity.
6.QTc prolongation
7.Hypokalemia
8.Recieved with Class I or III anti-arrhythmia drugs
9.Judged inappropriate by physicians.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Sakaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Endocrine & Breast Surgery
Zip code
Address
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
075-251-5534
ksak@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Sakaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Endocrine & Breast Surgery
Zip code
Address
465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
+81-75-251-5534
Homepage URL
ksak@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 30 | 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
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
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | 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
| 2010 | Year | 09 | Month | 29 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005149
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| Registered date | File name |
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| Registered date | File name |
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