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

Recruiting now

Conditions studied: Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT05916755

Run by

Vall d'Hebron Institute of Oncology

People needed

100

Starts

2023-01-13

Expected to finish

2029-12-01

Last updated by the study team

2023-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Metastatic disease on imaging (stage 4)

Where it is running

• Vall d'Hebron Institute of Oncology — Barcelona, Spain (enrolling)

Full record on ClinicalTrials.gov

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