UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of risk-reducing mastectomy for hereditary breast and ovarian cancer syndrome with BRCA1/2 mutation
Acronym	Feasibility study of risk-reducing mastectomy for BRCA1/2 mutation
Scientific Title	Feasibility study of risk-reducing mastectomy for hereditary breast and ovarian cancer syndrome with BRCA1/2 mutation
Scientific Title:Acronym	Feasibility study of risk-reducing mastectomy for BRCA1/2 mutation
Region	Japan

Condition
Condition	Hereditary Breast and Ovarian Cancer Syndrome
Classification by specialty	Breast surgery Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the safety of risk-reducing mastectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of the adverse event during risk-reducing mastectomy
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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	risk-reducing mastectomy
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. Women with BRCA1/2 pathogenic mutation who desire risk-reducing mastectomy 2. No clinical evidence of malignancy in the breast 3. ECOG Performance Status 0-1 4. Without major organ disorder 5. Age >=20 6. Understanding that medical expenses of the risk-reducing mastectomy is not covered by insurance 7. Written informed consent
Key exclusion criteria	1. Patients with reccurent or metastatic breast cancer 2. Patients with other factors not eligible for this study
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Masakazu Middle name Last name Toi
Organization	Kyoto University Hospital
Division name	Breast Surgery
Zip code	606-8507
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	1st name Masahiro Middle name Last name Takada
Organization	Kyoto University Hospital
Division name	Breast Surgery
Zip code	606-8507
Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3660
Homepage URL
Email	masahiro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida Konoe, Sakyo-ku, Kyoto, Japan
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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	2018 Year 04 Month 01 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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 23 Day
Date of IRB	2018 Year 07 Month 09 Day
Anticipated trial start date	2018 Year 07 Month 09 Day
Last follow-up date	2028 Year 07 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 23 Day
Last modified on	2020 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036379