Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform
Recruiting · NCT05916755 · Observational (researchers observe without assigning treatment) · Lead sponsor: Vall d'Hebron Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
ChemotherapyMicrobiome analysisPBMCs phenotypingPembrolizumabRNA-SequencingTCR-β repertoire sequencingWhole Genome SequencingctDNA analysis
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
1 location listed.
- Vall d'Hebron Institute of Oncology - Barcelona, Spain