COGNITION: Genomics-Guided Precision Oncology in Early High-Risk Breast Cancer
Recruiting · NCT05906407 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
12 locations listed.
- 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
- University Hospital Ulm - Ulm, Germany
- University Hospital Würzburg - Würzburg, Germany