UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041493
Receipt number 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 2021/07/14 15:20:16

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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 or person

Institute

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

Institute

Department

Personal name



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

156

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

Completed

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 09 Day

Last follow-up date

2021 Year 02 Month 08 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

2021 Year 07 Month 14 Day



Link to view the page

Value
https://center6.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