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Search / Trial NCT05916755

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

Launched by VALL D'HEBRON INSTITUTE OF ONCOLOGY · Jun 20, 2023

Trial Information

Current as of August 29, 2025

Recruiting

Keywords

Circulating Biomarkers Clinical Tool Immune Checkpoint Inhibitors Integrative Algorithm Microbiome Multiomics Neoadjuvant Chemotherapy Predictive Biomarkers Radiomics Rna Sequencing Triple Negative Breast Cancer Wgs

ClinConnect Summary

This clinical trial is looking to improve treatment for patients with triple-negative breast cancer (TNBC), a type of breast cancer that does not respond to certain hormone therapies. The study will include patients with stage II-III TNBC who are about to start chemotherapy, and some may also receive a treatment called an immune checkpoint inhibitor, which helps the immune system fight cancer. Researchers will analyze samples from different tissues to find biological markers that can predict how well patients will respond to these treatments. The goal is to create a helpful tool for doctors to make better treatment decisions for their patients.

To participate, patients need to be at least 18 years old and have a confirmed diagnosis of stage II-III TNBC that has not spread to other parts of the body. This trial is currently recruiting participants, and both men and women are welcome. If you join, you can expect to provide various tissue samples and undergo assessments to help researchers understand how these treatments work and who might benefit the most from them.

Gender

ALL

Eligibility 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)

About Vall D'hebron Institute Of Oncology

The Vall d'Hebron Institute of Oncology (VHIO) is a leading research institution dedicated to advancing cancer treatment and prevention through innovative clinical trials and translational research. Affiliated with the Vall d'Hebron University Hospital in Barcelona, VHIO integrates cutting-edge scientific discovery with clinical expertise, fostering collaboration among oncologists, researchers, and industry partners. The institute is committed to improving patient outcomes by pioneering novel therapeutic approaches and personalized medicine strategies, thereby positioning itself at the forefront of global oncology research and clinical excellence.

Locations

Barcelona, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported