CATCH: Implementation of Genomics-guided Precision Medicine in Metastatic Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Genomic Profiling / Sequencing: Procedure: genomic profiling (Whole-Genome- / Exome-Sequencing + RNA-Sequencing) on metastatic biopsy lesions

Study summary

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

Primary outcome measure(s)

• Setup of the molecular profiling diagnostic platform and feasibility of genomic profiling in metastatic breast cancer. — 31/12/2030
  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. — 31/12/2030
  Patients enrolled in subsequent interventional clinical therapy trials.

Trial sites (12)

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