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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004294
Receipt No. 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

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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
Email 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
Email ksak@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005149

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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