Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform
Identification of Predictive Biomarkers of Response to Chemotherapy and Immune Checkpoint Inhibitors in Early Triple Negative Breast Cancer: an Integrative Multiomics Platform
Vall d'Hebron Institute of Oncology
100 participants
Jan 13, 2023
OBSERVATIONAL
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.
Eligibility
Inclusion Criteria4
- Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status)
- Stage 2 - 3 defined by the American Joint Committee of Cancer (AJCC) staging criteria 8th edition for breast cancer as assessed by the investigator based on radiological and/or clinical assessment
- Patient is a candidate to receive NACT with or without ICI as assessed by the investigator
- Patient is ≥ 18 years old at the time of consent to participate in this trial
Exclusion Criteria1
- Metastatic disease on imaging (stage 4)
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Interventions
Whole genome sequencing (WGS) will be performed in tumor tissue from baseline and from residual disease after neoadjuvant chemotherapy (NACT), if present.
RNA-Sequencing will be performed in tumor tissue from baseline and from residual disease after NACT (if present).
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 will be performed in plasma before and during NACT.
TCR-β repertoire sequencing will be performed in plasma before and during NACT.
PBMCs phenotyping will be performed in plasma before and during NACT.
Pembrolizumab will be given in combination with standard NACT.
Standard NACT will be given.
Locations(1)
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NCT05916755