Clinical trial Recruiting at 1 site Observational Ages 18 and up

Identifying biomarkers for treatment response in triple negative breast cancer

Official title: Identification of Predictive Biomarkers of Response to Chemotherapy and Immune Checkpoint Inhibitors in Early Triple Negative Breast Cancer: an Integrative Multiomics Platform

Run by Vall d'Hebron Institute of Oncology · NCT05916755 · Data updated 2026-11-12

This study is testing if certain biological markers in tissue samples can help doctors predict how well treatments will work for people with stage II-III triple negative breast cancer.

More Triple Negative Breast Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorVall d'Hebron Institute of Oncology
Academic / other
Drugs / interventionschemotherapy, pembrolizumab
Locations1 site (Barcelona)
StatusRecruiting
StartedJanuary 13, 2023
Main results expectedDecember 2026
Study endsDecember 2029
Registry record updatedJune 23, 2023
Trial IDNCT05916755 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with histologically confirmed stage II-III triple negative breast cancer who are eligible for neoadjuvant chemotherapy.

Probably not a fit

Patients with metastatic disease or those not eligible for neoadjuvant chemotherapy will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with stage II-III triple negative breast cancer (TNBC) who are candidates for neoadjuvant chemotherapy, with or without immune checkpoint inhibitors. It aims to analyze various tissue samples using multiomics approaches, including whole genome sequencing and microbiome analysis, to establish predictive biomarkers of treatment response. The study will integrate data from these analyses to develop a clinical tool that assists clinicians in making informed treatment decisions for TNBC patients.

Why it matters

Potential benefit: If successful, this study could lead to personalized treatment strategies that improve outcomes for patients with triple negative breast cancer.

How similar studies have gone: Other studies have shown promise in using multiomics approaches to identify biomarkers in cancer treatment, suggesting potential success for this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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's running

  • Vall d'Hebron Institute of Oncology
    Barcelona, Spain
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.