UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients
Title of the study (Brief title)	Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Reveal the side effects and QOL after the start of endocrine treatment for pre-menopausal breast cancer patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	side effect of the incidence of post-dose after 3 months and QOL
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. premenopausal women 2. Breast cancer patients with hormone receptor-positive 3. Patients scheduled to administer the LH-RH agonist 4. Preoperative or postoperative hormone receptor-positive patient , hormone receptor-positive patients with no prior treatment as metastatic or recurrent treatment
Key exclusion criteria	1. Patients undergoing total hysterectomy surgery of the uterus 2. Patients registration to this study is deemed difficult due to mental disorders clinically relevant
Target sample size	100

Research contact person
Name of lead principal investigator	Yasunori Miyamoto
Organization	Hamamatsu Medical Center
Division name	Division of Pharmacy
Address	Tomidzuka-cho 328 Nakaku Hamamatsu Shizuoka
TEL	053-453-7111
Email	ymiyamo@hmedc.or.jp

Public contact
Name of contact person	Yasunori Miyamoto
Organization	Hamamatsu Medical Center
Division name	Division of Pharmacy
Address	Tomidzuka-cho 328 Nakaku Hamamatsu Shizuoka
TEL	053-453-7111
Homepage URL
Email	ymiyamo@hmedc.or.jp

Sponsor
Institute	Hamamatsu Medical Center, Division of Pharmacy
Institute
Department

Funding Source
Organization	Hamamatsu Medical Center, Division of Pharmacy
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	浜松医療センター（静岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 15 Day
Anticipated trial start date	2016 Year 07 Month 12 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry	2018 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To assess the situation and QOL of side effects on patients who meet the selection criteria

Management information
Registered date	2016 Year 07 Month 11 Day
Last modified on	2018 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026421