Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| ctDNA analysis | Diagnostic Test | — | UNRESOLVED |
| Microbiome analysis | Diagnostic Test | — | UNRESOLVED |
| PBMCs phenotyping | Diagnostic Test | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| RNA-Sequencing | Diagnostic Test | — | UNRESOLVED |
| TCR-β repertoire sequencing | Diagnostic Test | — | UNRESOLVED |
| Whole Genome Sequencing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- Pembrolizumab + neoadjuvant chemotherapy
- interventionNames
- Diagnostic Test: Whole Genome Sequencing
- Diagnostic Test: RNA-Sequencing
- Diagnostic Test: Microbiome analysis
- Diagnostic Test: ctDNA analysis
- Diagnostic Test: TCR-β repertoire sequencing
- Diagnostic Test: PBMCs phenotyping
- Drug: Pembrolizumab
- Drug: Chemotherapy
- label
- Cohort B
- description
- Neoadjuvant chemotherapy
- interventionNames
- Diagnostic Test: Whole Genome Sequencing
- Diagnostic Test: RNA-Sequencing
- Diagnostic Test: Microbiome analysis
- Diagnostic Test: ctDNA analysis
- Diagnostic Test: TCR-β repertoire sequencing
- Diagnostic Test: PBMCs phenotyping
- Drug: Chemotherapy
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Metastatic disease on imaging (stage 4)
References
Publications (0)
Data not yet available