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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041493
Receipt No. R000047323
Scientific Title A multi-institutional, retrospective, translational study of the relationship between histological immune-related signatures and clinical benefit of paclitaxel + bevacizumab therapy in HER2-negative advanced breast cancer
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/31

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Basic information
Public title A multi-institutional, retrospective, translational study of the relationship between histological immune-related signatures and clinical benefit of paclitaxel + bevacizumab therapy in HER2-negative advanced breast cancer
Acronym TRI-BE study
Scientific Title A multi-institutional, retrospective, translational study of the relationship between histological immune-related signatures and clinical benefit of paclitaxel + bevacizumab therapy in HER2-negative advanced breast cancer
Scientific Title:Acronym TRI-BE study
Region
Japan

Condition
Condition HER2-negative advanced breast cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore pathological biomarkers for PB therapy by retrospective evaluation of the association between immune-related signatures of archived tissue and clinical efficacy of PB therapy.
Basic objectives2 Others
Basic objectives -Others Exploring pathological biomarkers for PB therapy.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1.Expression-status of immune-related signatures in primary site
2.Relationships between overall survival (OS)/time-to-treatment failure (TTF) and expression status of immune-related signatures in primary site
Key secondary outcomes 1.Relationships between overall survival (OS)/time-to-treatment failure (TTF) and expression-status of immune-related signatures in metastatic site
2.Relationships between peripheral immune-related markers/nutritional markers and expression-status of immune-related signatures in metastatic site
3.Changes in markers of epithelial-mesenchymal transition between primary site and metastatic site
4.Relationships between peripheral immune-related markers/nutritional markers and clinical efficacy

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 Male and Female
Key inclusion criteria HER2-ABC patients who underwent PB therapy as their first-/second- line chemotherapy between January 2011 to December 2016 at participating institutes (Shizuoka Cancer Center, Hiroshima City Hiroshima Citizens Hospital, and Fukuyama City Hospital)
Key exclusion criteria Not applicable
Target sample size 156

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Sugino
Organization Shizuoka Cancer Center, Shizuoka
Division name Division of Pathology
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Email t.sugino@scchr.jp

Public contact
Name of contact person
1st name Junichiro
Middle name
Last name Watanabe
Organization Shizuoka Cancer Center, Shizuoka
Division name Division of Breast Oncology
Zip code 411-8777
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL 055-989-5222
Homepage URL
Email j.watanabe@scchr.jp

Sponsor
Institute The Mt.Fuji Foundation for Healthcare Innovation and Cluster Development Pharma Valley Center
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Biomedical Statistics and Bioinformatics, Kyoto University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shizuoka Cancer Center Institutional Review Board
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Tel 055-989-5222
Email tansaku_office@scchr.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 静岡県立静岡がんセンター(静岡県)、広島市立広島市民病院(広島県)、福山市立福山市民病院(広島県)
Shizuoka Cancer Center (Shizuoka prefecture), Hiroshima City Hiroshima Citizens Hospital (Hiroshima pref.), Fukuyama City Hospital (idem)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 01 Day

Related information
URL releasing protocol Not Applicable
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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 02 Day
Date of IRB
2020 Year 08 Month 21 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Relationships between peripheral immune-related markers and efficacy of anticancer therapy have been reported, however, relationship between peripheral immune-related markers and local immune-related signatures has not been clarified yet. To clarify this unsolved clinical question, this retrospective, translational study was planned.

Management information
Registered date
2020 Year 08 Month 21 Day
Last modified on
2020 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047323

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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