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NCT05916755Recruiting

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 · Last updated 23 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
8 May 2023
Start date
13 Jan 2023
Primary completion date
Dec 2026
Lead sponsor
Vall d'Hebron Institute of Oncology
NCT number
NCT05916755

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 13 Jan 2023 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Metastatic disease on imaging (stage 4)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vall d'Hebron Institute of Oncology
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.