Translational research on a prospective observational study of atezolizumab in patients with triple-negative breast cancer (JBCRG-C08)

Translational research on a prospective observational study of atezolizumab in patients with triple-negative breast cancer (JBCRG-C08) - Translational research on ATTRIBUTE trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045279

Enrollment

Registered

2021-08-27

Start date

2021-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple-negative Breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Paitients included in ATTRIBUTE trial(UMIN000041747)

Exclusion criteria

Exclusion criteria: Paitients excluded from ATTRIBUTE trial(UMIN000041747)

Design outcomes

Primary

Measure	Time frame
Association of Progression-Free Survival (PFS) with Peripheral Blood Biomarker Cell Fraction Including Discriminant Formula and Its Functional Molecular Expression.	—

Secondary

Measure	Time frame
(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)	—

Measure

Time frame

(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)

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Countries

Japan

Contacts

Public ContactFumikata Hara

Cancer Institute Hospital of JFCR Breast Oncology Center

fumikata.hara@jfcr.or.jp03-3520-0111

Outcome results