Recruiting

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

ClinicalTrials.gov IDNCT05906407

PhaseNot Applicable

Enrollment2000

SponsorGerman Cancer Research Center

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Early-Stage Breast Cancer, Neoadjuvant Therapy

About this study

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.

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

Primary outcomes

Comprehensive assessment of clinical patient data, collection of biomaterial and implementation of genomics- / molecular- and immune- guided precision medicine in eBC into the clinics. (31/12/2028)
Setting up a clinical and multidimensional, molecular diagnostic registry platform for patients with eBC and high risk for relapse. (31/12/2028)
Assessment of feasibility and retrieval of the logistical, clinical and information basis to screen and enroll patients for independent molecular-driven intervention trials (independent of this registry, e.g. COGNITION-GUIDE). (31/12/2028)

Eligibility information

Inclusion Criteria: * Female and male breast cancer patients aged ≥18 years. * Patients with primary early breast cancer (irrespective of subtypes) or - as an exception - patients with isolated loco-regional relapses that can be treated with a curative intention * Study entry is possible for patients with primary eBC at three timepoints: * Option A: patients planned to receive neoadjuvant chemotherapy are enrolled before starting the neoadjuvant treatment * Option B: patients with clinical non-complete response can be enrolled after the last cycle of neoadjuvant chemotherapy before surgery Note: Option A/B are strongly preferred entry time-points * Option C: eBC patients after surgery and planned or conducting standard-of-care (SoC) post-neoadjuvant chemotherapy can be enrolled after surgery until the last cycle of standard post-neoadjuvant chemotherapy, if they fulfill the following criteria * HER2+ BC or TNBC: non-pCR * HR+/HER2- BC: non-pCR and CPS-EG score ≥ 3 or non-pCR, ypN+ and CPS-EG-score ≥ 2 Note: Option C is not the preferred entry time-point Note: in case of loco-regional relapse, neoadjuvant treatment is not mandatory * Patients must be willing to donate a recent tumour sample to the registry Note: fresh tumour tissue is preferred * Patients, who agreed to and were able to sign the informed consent form (ICF). Exclusion Criteria: * Patients who did not sign or withdrew the informed consent form (ICF). * Inability to retrieve tissue for molecular profiling Any physical or mental handicap or severe comorbidities that would hamper the adequate cooperation with the patient.

Study locations

University Hospital Augsburg, Augsburg, Germany
Charité - Berlin, Berlin, Germany
University Hospital Köln, Cologne, Germany
Medical Faculty and University Hospital Carl Gustav Carus, Dresden, Germany
University Hospital Erlangen, Erlangen, Germany
University Hospital Essen, Essen, Germany
National Center for Tumor Diseases (NCT) Heidelberg, Heidelberg, Germany
Caritas Hospital St. Josef, Regensburg, Germany
Robert Bosch Hospital Stuttgart, Stuttgart, Germany
University Hospital Tübingen, Tübingen, Germany

Showing 10 of 12 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.