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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-100
SponsorGerman Cancer Research Center

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Genomic Profiling / Sequencing

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
31/12/2030
2

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.

Time frame
31/12/2030

Secondary outcomes

1

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).

Time frame
31/12/2030

Other outcomes

Sponsors and contacts

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German Cancer Research Center

Lead sponsor

University Hospital Heidelberg

Collaborator