Biomarker analysis: Phase II study of nivolumab + abemaciclib + endocrine therapy in patients with HR-positive HER2-negative metastatic breast cancer (NEWFLAME) WJOG11418B-TR

Biomarker analysis: Phase II study of nivolumab + abemaciclib + endocrine therapy in patients with HR-positive HER2-negative metastatic breast cancer (NEWFLAME) WJOG11418B-TR - NEWFLAMTR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036970

Enrollment

Registered

2019-06-05

Start date

2019-06-17

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

Hormone receptor positive and HER2-negative advanced breast cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results