RecruitingNCT05916755

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

Sponsor

Vall d'Hebron Institute of Oncology

Enrollment

100 participants

Start Date

Jan 13, 2023

Study Type

OBSERVATIONAL

Conditions

Triple-Negative Breast Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting biological samples (tumor tissue, blood) from patients with triple-negative breast cancer (TNBC) before and during immunotherapy to identify biomarkers that predict who will respond well to treatment. **You may be eligible if...** - You have confirmed triple-negative breast cancer (ER, PR, and HER2 negative) - Your cancer is stage 2 or 3 - You are scheduled to receive chemotherapy plus immunotherapy before surgery (neoadjuvant treatment) - You are able to undergo tumor biopsies **You may NOT be eligible if...** - You have a different breast cancer subtype - Your cancer has spread to distant organs (stage IV) - You are not receiving immunotherapy as part of your treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTWhole Genome Sequencing

Whole genome sequencing (WGS) will be performed in tumor tissue from baseline and from residual disease after neoadjuvant chemotherapy (NACT), if present.

DIAGNOSTIC_TESTRNA-Sequencing

RNA-Sequencing will be performed in tumor tissue from baseline and from residual disease after NACT (if present).

DIAGNOSTIC_TESTMicrobiome 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.

DIAGNOSTIC_TESTctDNA analysis

ctDNA analysis will be performed in plasma before and during NACT.

DIAGNOSTIC_TESTTCR-β repertoire sequencing

TCR-β repertoire sequencing will be performed in plasma before and during NACT.

DIAGNOSTIC_TESTPBMCs phenotyping

PBMCs phenotyping will be performed in plasma before and during NACT.

DRUGPembrolizumab

Pembrolizumab will be given in combination with standard NACT.

DRUGChemotherapy

Standard NACT will be given.