Biomarker analysis: Phase II study of nivolumab + abemaciclib + endocrine therapy in patients with HR-positive HER2-negative metastatic breast cancer (NEWFLAME) WJOG11418B-TR
Not Applicable
- Conditions
- Hormone receptor positive and HER2-negative advanced breast cancer
- Registration Number
- JPRN-UMIN000036970
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 53
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method