Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform
NCT ID: NCT05916755
Last Updated: 2023-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-01-13
2029-12-31
Brief Summary
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Detailed Description
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Objectives: (1) To establish predictive biomarkers of response to NACT + ICI in eTNBC by correlating data coming from different layers of omics performed in different tissues, together with imaging, with pCR, EFS, and overall survival (OS). (2) To integrate data generated from (1), and clinical data, and explore multivariate predictive models of response to NACT + ICI.
Methods: Patients with stage II-III TNBC candidates to receive NACT +/- ICI will be included. Collected samples and type of analysis: (1) Tumor tissue (baseline and from residual disease after NACT): whole genome sequencing (WGS) and RNA-Seq will be performed (Hartwig sequencing platform and analytical pipeline), tissue immune phenotyping (PD-L1, T and B infiltrating lymphocytes, among others), and microbiome analysis (16S rRNA); (2) Blood (before and during NACT): circulating tumor DNA (ctDNA) analysis (targeted gene panel and shallow WGS), T-cell receptor beta (TCR-β) repertoire sequencing and analysis (ImmunoSeq hsTCRβ kit and immunoSEQ), and peripheral blood mononuclear cells (PBMCs) phenotyping; (3) Stools and saliva (before and during NACT): microbiome analysis (16S rRNA); (4) Breast MRI imaging (before and after NACT): radiomics analysis. Multiple algorithms including Multiple Kernel Learning, Multi-Omics Factor Analysis (MOFA) and Method for the Functional Integration of Spatial and Temporal Omics data (MEFISTO) will then be used to look for an integrative predictive algorithm that incorporates multi-parameter inputs. The aim is to provide more personalized treatment efficacy and risk for relapse estimates.
Expected outcome: To develop a clinical tool to assist clinicians in the process of treatment decision-making in eTNBC, in order to maximize patient's benefit and quality of life, while minimizing AEs and financial burden to the health system.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Pembrolizumab + neoadjuvant chemotherapy
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.
Cohort B
Neoadjuvant chemotherapy
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.
Chemotherapy
Standard NACT will be given.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
18 Years
ALL
No
Sponsors
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Vall d'Hebron Institute of Oncology
OTHER
Responsible Party
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Locations
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Vall d'Hebron Institute of Oncology
Barcelona, , Spain
Countries
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Facility Contacts
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Other Identifiers
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PR(AG)165-2021
Identifier Type: -
Identifier Source: org_study_id
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