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COGNITION: Genomics-Guided Precision Oncology in Early High-Risk Breast Cancer

NCT05906407 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-03-19

No results posted yet for this study

Summary

The COGNITION diagnostic platform elucidates the biomarker profile of neoadjuvant chemotherapy-resistant residual bulk tumors in high risk early breast cancer patients. The major goal is to provide a framework for genomic profiling, which serves as infrastructure for systematic biomarker-screening and -stratification for concise therapy-arm allocation in the interventional clinical phase II trial COGNITION-GUIDE (NCT05332561).

In patients, who display a poor response to standard-of-care neoadjuvant chemotherapy, tissue samples before and after neoadjuvant therapy are subjected together with blood samples to comprehensive genomic profiling to identify patients potentially benefiting from biomarker-guided interventions in COGNITION-GUIDE.

Samples not required for standard-of-care clinical procedures or genomic profiling are systematically collected in a dedicated bio-repository to fuel translational scientific companion programs. The continuously growing comprehensive database serves as an integrative resource for systematic, prospective multidimensional data collection (clinical records, biomaterial, genomic data).

In summary, the overarching goal is to generate a precision oncology platform i) to identify clinically-actionable biomarkers and drug targets that drive genomics-guided therapies and ii) to couple the observational, diagnostic registry platform to the independent, biomarker-stratified clinical therapy trial COGNITION-GUIDE.

Conditions

Interventions

OTHER

Genomic Profiling / Sequencing

Procedure: genomic profiling (Whole-Genome- / Exome-Sequencing + RNA-Sequencing) in high-risk early breast cancer patients pre- and post neoadjuvant therapy

Sponsors & Collaborators

  • University Hospital Heidelberg

    collaborator OTHER

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • German Cancer Research Center

    lead OTHER

Principal Investigators

  • Peter Lichter, PhD · German Cancer Research Center (DKFZ) Heidelberg

  • Andreas Schneeweiss, MD · National Center for Tumor Diseases, Heidelberg

  • Verena Thewes, PhD · National Center for Tumor Diseases, Heidelberg

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-19
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05906407 on ClinicalTrials.gov