Unique ID issued by UMIN | UMIN000041493 |
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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 |
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
TRI-BE study
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
TRI-BE study
Japan |
HER2-negative advanced breast cancer
Hematology and clinical oncology |
Malignancy
NO
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.
Others
Exploring pathological biomarkers for PB therapy.
Exploratory
Not applicable
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
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
Observational
Not applicable |
Not applicable |
Male and Female
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)
Not applicable
156
1st name | Takashi |
Middle name | |
Last name | Sugino |
Shizuoka Cancer Center, Shizuoka
Division of Pathology
411-8777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
055-989-5222
t.sugino@scchr.jp
1st name | Junichiro |
Middle name | |
Last name | Watanabe |
Shizuoka Cancer Center, Shizuoka
Division of Breast Oncology
411-8777
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
055-989-5222
j.watanabe@scchr.jp
The Mt.Fuji Foundation for Healthcare Innovation and Cluster Development Pharma Valley Center
Chugai Pharmaceutical Co., Ltd.
Profit organization
Japan
Biomedical Statistics and Bioinformatics, Kyoto University
Shizuoka Cancer Center Institutional Review Board
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
055-989-5222
tansaku_office@scchr.jp
NO
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)
2020 | Year | 09 | Month | 01 | Day |
Not Applicable
Unpublished
156
Completed
2020 | Year | 07 | Month | 02 | Day |
2020 | Year | 08 | Month | 21 | Day |
2020 | Year | 09 | Month | 09 | Day |
2021 | Year | 02 | Month | 08 | Day |
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.
2020 | Year | 08 | Month | 21 | Day |
2021 | Year | 07 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047323
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