UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	International Retrospective Cohort Study of Locoregional and Systemic Therapy in Oligometastatic Breast Cancer
Title of the study (Brief title)	OLIGO-BC1
Region	Japan Asia(except Japan)

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

Objectives
Narrative objectives1	To validate locoregional therapy and systemic therapy in oligometastatic BC by an international retrospective cohort study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is the estimated 5-year OS after the initial diagnosis of oligometastatic BC.
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1 recurrent case performed by curative operation 2 oligometastatic breast cancer defined as in the protocol 3 oligometastatic breast cancer diagnosed between 2005 and 2012 4 systemic therapy or locoregional and systemic therapy performed 5 the order of locoregional therapy and systemic therapy is decided at the physicians discretion
Key exclusion criteria	1 recurrent case with any kind of pleural effusion 2 recurrent case with any kind of ascites beyond a physiological condition 3 recurrent case with any kind of pericardiac effusion 4 recurrent case with a non-curative operation of primary breast cancer, except for cases with a positive surgical margin with noninvasive cancer or cases of sentinel lymph nodes with isolated tumor cells or micrometastases in which axillary lymph node dissection was not performed 5 recurrent case of ipsilateral breast tumor 6 recurrent case with no pathological confirmation of primary breast cancer 7 recurrent case with a past history of other invasive cancer 8 recurrent case with severe or life threatening comorbidity due to myocardial infarction, cerebral infarction, diabetes mellitus, autoimmune disease
Target sample size	700

Research contact person
Name of lead principal investigator	Shigeru Imoto
Organization	Kyorin University School of Medicine
Division name	Department of Breast Surgery
Address	6-20-2 Shinkawa Mitaka Tokyo
TEL	0422-47-5511
Email	imoto@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Mami Sakurai
Organization	FACO (Federation of Asian Clinical Oncology)
Division name	Office
Address	+81-3-55420546
TEL	03-5542-0546
Homepage URL
Email	faco-office@jsco.or.jp

Sponsor
Institute	FACO (Federation of Asian Clinical Oncology)
Institute
Department

Funding Source
Organization	FACO (Federation of Asian Clinical Oncology)
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	2018 Year 01 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 11 Month 20 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2020 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	o hypothesize that locoregional therapy has more advantage of OS in oligometastatic BC, the 5-year OS rates of cases treated with locoregional and systemic therapy and cases treated with systemic therapy alone are expected to be 50% and 40%, respectively. The estimated sample size is calculated to be the number of 698 cases (349 cases in each group) needed to prove the superiority of survival with a two-sided type I error rate of 5% and a statistical power of 80%. Thus, we need to register 700 cases, i.e., 234 cases each from investigators of KACO, CSCO and JSCO. To confirm the hypothesis, events of 400 cases should be needed.

Management information
Registered date	2017 Year 11 Month 20 Day
Last modified on	2018 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034310