UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045279 |
|---|---|
| Receipt number | R000050171 |
| Scientific Title | Translational research on a prospective observational study of atezolizumab in patients with triple-negative breast cancer (JBCRG-C08) |
| Date of disclosure of the study information | 2021/08/27 |
| Last modified on | 2021/08/27 08:34:46 |
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Basic information
Public title
Translational research on a prospective observational study of atezolizumab in patients with triple-negative breast cancer (JBCRG-C08)
Acronym
Translational research on ATTRIBUTE trial
Scientific Title
Translational research on a prospective observational study of atezolizumab in patients with triple-negative breast cancer (JBCRG-C08)
Scientific Title:Acronym
Translational research on ATTRIBUTE trial
Region
| Japan |
Condition
Condition
Triple-negative Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether peripheral blood biomarkers can predict the efficacy of therapies including atezolizumab.
To identify other novel peripheral blood biomarkers and to clarify the immunological significance of these biomarkers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of Progression-Free Survival (PFS) with Peripheral Blood Biomarker Cell Fraction Including Discriminant Formula and Its Functional Molecular Expression.
Key secondary outcomes
(1) Relationship between the following items and peripheral blood biomarker cell fractions including discriminant formula and their functional molecule expression
Overall Response Rate
Clinical Benefit Rate
Overall Survival
Adverse events (autoimmune-related adverse events: irAEs only)
The evaluation of adverse events shall be in accordance with the Common Terminology Criteria for Adverse Events v5.0 Japanese translation of JCOG (hereinafter referred to as CTCAE v5.0-JCOG).
(2) The following analyses will be performed using various peripheral blood biomarker cell fractions to analyze their immunological significance.
i. TCR repertoire analysis
ii. Identification of MHC binding antigens
iii. Methylome analysis
iv. Analysis of phosphorylation signaling pathways
v. Multicolor TIL analysis of tumor tissue
vi. Single Cell RNA-seq analysis
Translated with www.DeepL.com/Translator (free version)
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
Paitients included in ATTRIBUTE trial(UMIN000041747)
Key exclusion criteria
Paitients excluded from ATTRIBUTE trial(UMIN000041747)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Fumikata |
| Middle name | |
| Last name | Hara |
Organization
Cancer Institute Hospital of JFCR
Division name
Breast Oncology Center
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo, Japan
TEL
03-3520-0111
fumikata.hara@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Fumikata |
| Middle name | |
| Last name | Hara |
Organization
Cancer Institute Hospital of JFCR
Division name
Breast Oncology Center
Zip code
135-8550
Address
3-8-31, Ariake, Koto, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
fumikata.hara@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital of JFCR
Breast Oncology Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital of JFCR, Ethics Commitee
Address
3-8-31, Ariake, Koto, Tokyo, Japan
Tel
03-3520-0111
fumikata.hara@jfcr.or.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
| 2021 | Year | 08 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Translational research associated with a multicenter, prospective, observational study using a central registry system
Study Period
Enrollment period: 1 year and 6 months from the date of first enrollment of study subjects
Follow-up period: 1 year and 6 months from the date of last case enrollment
Analysis period: 1 year from the end of the follow-up period
Study period: 4 years from the date of enrollment of the first study subject
As translational research associated with the Japan Breast Cancer Research Group (JBCRG) prospective observational study of atezolizumab in triple-negative breast cancer patients (JBCRG-C08), we developed a peripheral blood biomarker (discriminant formula) to evaluate the efficacy of atezolizumab in patients with triple-negative breast cancer. The purpose of this study is to evaluate whether our developed peripheral blood biomarkers (discriminant formula) can be used to predict the efficacy of therapies including atezolizumab.
In addition, we will identify other novel peripheral blood biomarkers and clarify their immunological significance.
Management information
Registered date
| 2021 | Year | 08 | Month | 27 | Day |
Last modified on
| 2021 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050171
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
