UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of bilateral salpingo-oophorectomy for pre-menopausal patients with metastatic luminal-type breast cancer
Title of the study (Brief title)	Feasibility study of bilateral salpingo-oophorectomy for pre-menopausal patients with metastatic luminal-type breast cancer
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1. To evaluate safety of the surgery 2. To evaluate adverse events after the surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Adverse events during the surgery 2. Adverse events after the surgery
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	Maneuver
Interventions/Control_1	Bilateral salpingo-oophorectomy
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	60 years-old >
Gender	Female
Key inclusion criteria	1. pathologically proven breast cancer 2. pre-menopaose before starting treatment 3. recurrent or metastatic breast cancer 4. ER/PgR positive breast cancer 5. plan for endocrine treatment 6. ECOG Performance Status 0-1 7. no major organ disfunction 8. life expectancy > 6 months 9. understanding the sugery will not covered by insurance 10. informed consent
Key exclusion criteria	1. pregnant or lactation 2. other reasons by which researchers decide that the patient is not suitable for this study
Target sample size	25

Research contact person
Name of lead principal investigator	Masakazu Toi
Organization	Graduate School of Medicine, Kyoto University
Division name	Breast Surgery
Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3660
Email	toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Masahiro Takada
Organization	Graduate School of Medicine, Kyoto University
Division name	Breast Surgery
Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3111
Homepage URL
Email	masahiro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Hospital
Institute
Department

Funding Source
Organization	Kyoto University Hospital
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 06 Day
Anticipated trial start date	2018 Year 04 Month 09 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	2017 Year 11 Month 06 Day
Last modified on	2019 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034092