UMIN-CTR Clinical Trial

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
Email	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
Email	fumikata.hara@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital of JFCR Breast Oncology Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050171