UMIN-CTR Clinical Trial

Basic information
Public title	Prospective cohort study of lung oligometastasis of breast cancer
Acronym	SBP-06
Scientific Title	Prospective cohort study of lung oligometastasis of breast cancer
Scientific Title:Acronym	SBP-06
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Prospective analysis of diagnosis, treatment strategy and prognosis of lung oligometastasis of breast cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival of lung oligometastasis of breast cancer
Key secondary outcomes	Efficacy and safety of surgery for lung oligometastasis of breast cancer

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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)First metastasis after curable breast cancer surgery (2)under 3 lung metastasesdiagnosed by CT, PET/CT or biposy. (3)only lung metastasis (4)ER, PgR and HER2 expression were diagnosed by primary breast cancer tumor
Key exclusion criteria	none
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Tadahiko Middle name Last name Shien
Organization	Okayama University Hospital
Division name	Breast and Endocrine surgery
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	+81862357265
Email	tshien@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Tadahiko Middle name Last name Shien
Organization	Setouchi Breast Project
Division name	Crinical trial committiee
Zip code	700-8558
Address	2-5-1 Shikata-cho. Kita-ku, Okayama
TEL	086-235-7265
Homepage URL
Email	tshien@md.okayama-u.ac.jp

Sponsor
Institute	Setouchi Breast Project
Institute
Department

Funding Source
Organization	Setouchi Breast Project
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	Okayama University Hospital, Ethics Committee
Address	1-5-2 Shikata-cho, Kita-ku
Tel	086-235-7265
Email	tshien@md.okayama-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	2015 Year 03 Month 31 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	No longer recruiting
Date of protocol fixation	2014 Year 10 Month 13 Day
Date of IRB	2014 Year 10 Month 13 Day
Anticipated trial start date	2014 Year 10 Month 13 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Diagnosis, treatment strategy and prognosis of lung oligometastasis of breast cancer

Management information
Registered date	2015 Year 03 Month 31 Day
Last modified on	2020 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018189