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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVall d'Hebron Institute of Oncology

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Metastatic disease on imaging (stage 4)

Trial design

Treatments tested in this trial

  • Whole Genome Sequencing
  • RNA-Sequencing
  • Microbiome analysis
  • ctDNA analysis
  • TCR-β repertoire sequencing
  • PBMCs phenotyping
  • Pembrolizumab
  • Chemotherapy

Treatment groups

100 Participants
are divided into 2 treatment groups