An observational study in Metastatic Breast Cancer, sponsored by German Cancer Research Center. Recruiting at 12 sites in Germany. Open to participants aged 14 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by German Cancer Research Center · Observational
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).
Study Flow
CATCH has the goal to implement personalized oncology workflows into the clinic. The clinical precision oncology core backbone encompasses a streamlined diagnostic end-to-end pipeline:
Patient screening and enrolment: Metastatic breast cancer (mBC) patients at initial diagnosis of locally-advanced-/ distant metastasis and any other clinical progress are screened for eligibility. The treating physician has to obtain written informed consent prior to enrolment.
Collection of biomaterial: Fresh-frozen tumor tissue from progressive prognostic-relevant metastatic lesions is collected during standard-of-care routine procedures at study entry. Consecutive biopsies can be offered at progress. Blood samples are taken at baseline (V1) to account for germline controls and can be sequentially repeated at 3-monthly intervals for monitoring of therapy response.
Processing and analyses of patient samples: Biomaterials are centrally processed (standard histology/IHC and pathology review for tumor content; analyte extraction, QC according to standardized, quality-controlled, accredited workflows (DIN EN ISO/IEC 17025). Analyte extraction on fresh-frozen tissue encompasses DNA, RNA and protein isolation.
Molecular profiling (Sequencing): Genomic profiling (DIN EN ISO/IEC 17025) is centrally processed to ensure standardization and encompasses whole-genome sequencing (WGS) on fresh-frozen tissue biopsies or whole-exome sequencing (WES) on FFPE specimens (in case of unsuccessful biopsy sampling on recent lesion due to low tumor cell content) complemented by RNA-sequencing.
Clinical bioinformatics /Data curation: Tumor- and treatment-relevant genomic aberrations together with standard clinical as well as histopathological parameters are analyzed and put into the clinical context to delineate biomarkers and actionable alterations as well as to tackle the underlying biology of treatment-resistance.
Molecular Tumor Board (MTB): Molecular data and conclusive biomarker profiles are discussed by clinicians, bioinformaticians, molecular biologists, human geneticists and pathologists in a weekly interdisciplinary MTB established at NCT Heidelberg. Treatment-relevant biomarkers and actionable drug targets are validated independently. Therapeutic options are prioritized within a molecular report.
Therapy Implementation: Patients will be informed in detail by the treating physician to discuss potential genetically-tailored treatment options. The major goal is to offer patients further interventional clinical trials and drive assignment towards genomics-guided matched biomarker / drug combinations.
Follow-up / Documentation Schedule: Clinical documentation is conducted by authorized study personal at study entry in a certified electronic case report form (eCRF) and subsequently every 3 months for at least 3 years, at any staging interval or cancer-specific therapy change to generate a comprehensive patient registry. To ascertain comprehensive follow-up, only patients will be enrolled who will be treated locally at the involved trial sites. Molecular data will be systematically collected to drive translational exploratory research projects.
The following data are collected and stored (baseline and follow-up assessments)
Translational scientific companion programs: Excess biomaterial not needed for the diagnostic precision oncology approach can be used for exploratory research (e.g. ex vivo approaches, liquid biopsies, immunophenotyping).
Results / Outcome Evaluation:Molecular data will be analysed and interpreted on complementary levels. Biomarkers and molecular aberrations such as mutations, amplifications and aberrant gene expression are evaluated for their tumor-relevance and clinical potential to assign patients for specific clinical trials with targeted treatment approaches.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →German Cancer Research Center is the lead sponsor of 49 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Advanced-stage / metastatic breast cancer patients (at the time point of progress)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: genomic profiling (Whole-Genome- / Exome-Sequencing + RNA-Sequencing) on metastatic biopsy lesions
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
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 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
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2017 (actual). Primary completion is estimated for Dec 2030, 162 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 162 months is above that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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German Cancer Research Center