NCT05652569

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jun 2017Dec 2030

Study Start

First participant enrolled

June 12, 2017

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

13.6 years

First QC Date

December 7, 2022

Last Update Submit

January 26, 2026

Conditions

Keywords

Metastatic Breast CancerStage IV Breast CancerPrecision OncologyGenomics-Guided Biomarker-StratificationPersonalized OncologyGenomic Profiling

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    31/12/2030

Secondary Outcomes (1)

  • Secondary outcome measures Building novel therapeutic hypothesis.

    31/12/2030

Interventions

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

Eligibility Criteria

Age14 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Advanced-stage / metastatic breast cancer patients (at the time point of progress)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University Hospital Augsburg

Augsburg, Germany

RECRUITING

Charité

Berlin, Germany

RECRUITING

University Hospital Köln

Cologne, Germany

RECRUITING

Medical Faculty and University Hospital Carl Gustav Carus

Dresden, Germany

RECRUITING

University Hospital Erlangen

Erlangen, Germany

RECRUITING

University Hospital Essen

Essen, Germany

RECRUITING

National Center for Tumor Diseases

Heidelberg, Germany

RECRUITING

Caritas Hospital St. Josef

Regensburg, Germany

RECRUITING

Robert-Bosch-Krankenhaus Stuttgart

Stuttgart, Germany

RECRUITING

University Hospital Tübingen

Tübingen, Germany

RECRUITING

University Hospital Ulm

Ulm, Germany

RECRUITING

University Hospital Würzburg

Würzburg, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fresh-frozen biopsy tissue and EDTA-blood

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Genetic ProfileBase Sequence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic BackgroundGenetic PhenomenaMolecular StructureBiochemical PhenomenaChemical PhenomenaGenetic Structures

Study Officials

  • Andreas Schneeweiss, MD

    National Center for Tumor Diseases, Heidelberg

    PRINCIPAL INVESTIGATOR
  • Peter Lichter, PhD

    German Cancer Research Center

    PRINCIPAL INVESTIGATOR
  • Verena Thewes, PhD

    National Center for Tumor Diseases, Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 15, 2022

Study Start

June 12, 2017

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations