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Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform
Sponsor: Vall d'Hebron Institute of Oncology
Summary
Patients with stage II-III Triple negative breast cancer (TNBC) candidates to receive neoadjuvant chemotherapy (NACT) +/- immune checkpoint inhibitor (ICI) will be included. Several samples from different tissues will be analyzed through different omics to establish predictive biomarkers of response to the treatment. Multiple algorithms will then be used to look for an integrative predictive algorithm that incorporates multi-parameter inputs in order to develop a clinical tool to assist clinicians in the process of treatment decision-making in TNBC.
Official title: Identification of Predictive Biomarkers of Response to Chemotherapy and Immune Checkpoint Inhibitors in Early Triple Negative Breast Cancer: an Integrative Multiomics Platform
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2023-01-13
Completion Date
2029-12
Last Updated
2023-06-23
Healthy Volunteers
No
Conditions
Interventions
Whole Genome Sequencing
Whole genome sequencing (WGS) will be performed in tumor tissue from baseline and from residual disease after neoadjuvant chemotherapy (NACT), if present.
RNA-Sequencing
RNA-Sequencing will be performed in tumor tissue from baseline and from residual disease after NACT (if present).
Microbiome analysis
Microbiome analysis will be performed in stools and saliva before, during NACT and at the end of adjuvant systemic therapy if adjuvant systemic therapy is clinically indicated.
ctDNA analysis
ctDNA analysis will be performed in plasma before and during NACT.
TCR-β repertoire sequencing
TCR-β repertoire sequencing will be performed in plasma before and during NACT.
PBMCs phenotyping
PBMCs phenotyping will be performed in plasma before and during NACT.
Pembrolizumab
Pembrolizumab will be given in combination with standard NACT.
Chemotherapy
Standard NACT will be given.
Locations (1)
Vall d'Hebron Institute of Oncology
Barcelona, Spain