About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Advanced-stage / metastatic breast cancer patients (at the time point of progress)
Trial design
Cohort
Prospective
Treatments tested in this trial
Genomic Profiling / Sequencing
Other interventionProcedure: genomic profiling (Whole-Genome- / Exome-Sequencing + RNA-Sequencing) on metastatic biopsy lesions
Treatment groups
Trial outcomes
Primary outcomes
Setup of the molecular profiling diagnostic platform and feasibility of genomic profiling in metastatic breast cancer.
Total number of advanced stage / metastatic breast cancer patients i) eligible for genomic profiling, ii) successfully genomically-profiled tumors, iii) with conclusive biomarker profiles.
Total number of patients eligible for clinical trials and targeted therapies based on clinical characteristics and comprehensive tumor features.
Patients enrolled in subsequent interventional clinical therapy trials.
Secondary outcomes
Secondary outcome measures Building novel therapeutic hypothesis.
To retrieve qualitative and quantitative biomarker-information on the genomic landscape of breast cancer to setup independent biomarker-guided interventional clinical trials (CATCH-GUIDE).
Sponsors and contacts
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German Cancer Research Center
Lead sponsor
University Hospital Heidelberg
Collaborator