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

RecruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

January 13, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2029

Conditions
Triple Negative Breast Cancer
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.

Trial Locations (1)

08035

RECRUITING

Vall d'Hebron Institute of Oncology, Barcelona

All Listed Sponsors
lead

Vall d'Hebron Institute of Oncology

OTHER