CATCH: Implementation of Genomics-guided Precision Medicine in Metastatic Breast Cancer
Recruiting · NCT05652569 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
CATCH is an indication-specific diagnostic platform, which drives the implementation of integrative, genomic profiling for metastatic breast cancer into the clinics. The main objective of this approach is to identify biomarkers and drug targets to guide targeted therapeutic interventions. Eligible are all metastatic breast cancer patients (independent of gender), irrespective of molecular subtype. At initial diagnosis of distant metastasis or progress at disease progression, biopsy samples from a prognostic-relevant metastasis are retrieved during standard-of-care procedures for central analyses, together with blood samples. In parallel to all standard-diagnostic measures, genomic and transcriptomic profiling is conducted to infer the underlying biology of the disease and identify patients who might profit from biomarker-guided interventions in clinical trials. 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 to i) identify clinically-actionable biomarkers and drug targets that drive genomics-guided therapies and ii) couple the observational, diagnostic registry platform to an increasing number of independent, biomarker-stratified clinical therapy trials (CATCH-GUIDE).
Who can take part
Inclusion criteria
- Female and male breast cancer patients ≥ 18 or if the legal guardian has agreed to the respective informed consent form (ICF)
- Patients with advanced or metastatic breast cancer (irrespective of clinical parameters such as TNM, subgroups, therapy lines)
- Patients, who agreed to and were able to sign the informed consent form.
Exclusion criteria
- Early breast cancer
- Inability to take a tissue bioptic sample due to reasons such as physical location of the lesion or health of the patient
- 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, 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 - Heidelberg, Germany
- Caritas Hospital St. Josef - Regensburg, Germany
- Robert-Bosch-Krankenhaus Stuttgart - Stuttgart, Germany
- University Hospital Tübingen - Tübingen, Germany
- University Hospital Ulm - Ulm, Germany
- University Hospital Würzburg - Würzburg, Germany