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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030047
Receipt No. R000034310
Scientific Title International Retrospective Cohort Study of Locoregional and Systemic Therapy in Oligometastatic Breast Cancer
Date of disclosure of the study information 2018/01/01
Last modified on 2018/11/12

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Basic information
Public title International Retrospective Cohort Study of Locoregional and Systemic Therapy in Oligometastatic Breast Cancer
Acronym OLIGO-BC1
Scientific Title International Retrospective Cohort Study of Locoregional and Systemic Therapy in Oligometastatic Breast Cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Shigeru Imoto
Organization Kyorin University School of Medicine
Division name Department of Breast Surgery
Zip code
Address 6-20-2 Shinkawa Mitaka Tokyo
TEL 0422-47-5511
Email imoto@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mami Sakurai
Organization FACO (Federation of Asian Clinical Oncology)
Division name Office
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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