UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036970 |
|---|---|
| Receipt number | R000041954 |
| Scientific Title | Biomarker analysis: Phase II study of nivolumab + abemaciclib + endocrine therapy in patients with HR-positive HER2-negative metastatic breast cancer (NEWFLAME) WJOG11418B-TR |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2023/01/10 09:53:13 |
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Basic information
Public title
Biomarker analysis: Phase II study of nivolumab + abemaciclib + endocrine therapy in patients with HR-positive HER2-negative metastatic breast cancer (NEWFLAME) WJOG11418B-TR
Acronym
NEWFLAMTR
Scientific Title
Biomarker analysis: Phase II study of nivolumab + abemaciclib + endocrine therapy in patients with HR-positive HER2-negative metastatic breast cancer (NEWFLAME) WJOG11418B-TR
Scientific Title:Acronym
NEWFLAMTR
Region
| Japan |
Condition
Condition
Hormone receptor positive and HER2-negative advanced breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploratory analysis of biomarkers to identify the patients who benefit the combination of nivolumab with abemaciclib and endocrine therapy.
Basic objectives2
Others
Basic objectives -Others
Correlation between subsets defined by biomarker and PFS or OS.
Micro satellite instability (MSI), tumor mutation burden (TMB) determined using circulating tumor DNA (ctDNA)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PBMC subset analysis such as T cell, B cell, NK cell, monocyte, dendric cell, MDSC, T/B differentiated cell (CCR7, CD45RA, CD45RO, CD62L, etc.), immune check point/ exhaustion related molecules (CTLA-4, PD-1, PD-L1, LAG-3, Tim-3)
Gene analysis on PBMC
(CD4+T cell, CD8+ cell, NK cell, B cell, DC, granular cell)
Expression of cytokines using serum
ctDNA analysis using plasma for MSI and TMB
RNA sequencing using tumor tissue for IM signature and PD-L1 expression
Microbiota: 16s
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Subjects with HR positive and HER2-negative advanced breast cancer who are enrolled in WJOG11418B study and provide informed-consent to participate the study that requires blood, tumor tissue and stool requisition.
Key exclusion criteria
None
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Tsurutani |
Organization
Showa University
Division name
Advanced Cancer Translational research institute
Zip code
142-8666
Address
1-5-8,Hatanodai,Shinagawa-ku,Tokyo 142-8666,JAPAN
TEL
03-3784-8145
tsurutaj@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
556-0016
Address
Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee in Showa University
Address
1-5-8,Hatanodai,Shinagawa-ku,Tokyo 142-8666,JAPAN
Tel
03-3784-8145
tsurutaj@med.showa-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 05 | 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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To analyze immune-related molecules using blood and tumor tissue samples
Management information
Registered date
| 2019 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041954
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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