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

Recruitingn/aAges 18 Years - anyAllVall d'Hebron Institute of Oncology
NCT05916755 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 18 years old at the time of consent to participate in this trial Exclusion Criteria: * Metastatic disease on imaging (stage 4)
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What it tests

  • Whole Genome Sequencing
  • RNA-Sequencing
  • Microbiome analysis
  • ctDNA analysis
  • TCR-ฮฒ repertoire sequencing
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Where

1 site
Vall d'Hebron Institute of Oncology
Barcelona, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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