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Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform

NCT05916755 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-06-23

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

RNA-Sequencing

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

ctDNA analysis

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

DIAGNOSTIC_TEST

TCR-β repertoire sequencing

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

DIAGNOSTIC_TEST

PBMCs phenotyping

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

DRUG

Pembrolizumab

Pembrolizumab will be given in combination with standard NACT.

DRUG

Chemotherapy

Standard NACT will be given.

Sponsors & Collaborators

  • Vall d'Hebron Institute of Oncology

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-13
Primary Completion
2026-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05916755 on ClinicalTrials.gov