UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients
Title of the study (Brief title)	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	Koichi Sakaguchi
Organization	Kyoto Prefectural University of Medicine
Division name	Endocrine & Breast Surgery
Address	465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL	075-251-5534
Email	ksak@koto.kpu-m.ac.jp

Public contact
Name of contact person	Koichi Sakaguchi
Organization	Kyoto Prefectural University of Medicine
Division name	Endocrine & Breast Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000005149