Trial Title:
CATCH: Implementation of Genomics-guided Precision Medicine in Metastatic Breast Cancer
NCT ID:
NCT05652569
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Metastatic Breast Cancer
Stage IV Breast Cancer
Precision Oncology
Genomics-Guided Biomarker-Stratification
Personalized Oncology
Genomic Profiling
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Genomic Profiling / Sequencing
Description:
Procedure: genomic profiling (Whole-Genome- / Exome-Sequencing + RNA-Sequencing) on
metastatic biopsy lesions
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).
Detailed description:
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)
- patient identifier /demographics (including sex, age at diagnosis, family history)
- cancer type / medical history / characteristics diagnosis (including date of
diagnosis)
- clinical outcome / longitudinal disease assessments: relapse and progression
- genomic and transcriptomic data
- ECOG status
- sample information (e.g. specimen type, tumor histological type, anatomical
location, tissue analyses)
- health-related Quality-of-Life (QoL) / Patient-Reported Outcomes (PROs)
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.
Criteria for eligibility:
Study pop:
Advanced-stage / metastatic breast cancer patients (at the time point of progress)
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
14 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Augsburg
Address:
City:
Augsburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Nina Ditsch, MD
Facility:
Name:
Charité
Address:
City:
Berlin
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Jens-Uwe Blohmer, MD
Facility:
Name:
Medical Faculty and University Hospital Carl Gustav Carus
Address:
City:
Dresden
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Pauline Wimberger, MD
Facility:
Name:
University Hospital Erlangen
Address:
City:
Erlangen
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Peter Fasching, MD
Facility:
Name:
University Hospital Essen
Address:
City:
Essen
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Anja Welt, MD
Facility:
Name:
National Center for Tumor Diseases
Address:
City:
Heidelberg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Andreas Schneeweiss, MD
Facility:
Name:
University Hospital Köln
Address:
City:
Köln
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Wolfram Malter, MD
Facility:
Name:
Caritas Hospital St. Josef
Address:
City:
Regensburg
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Stephan Seitz, MD
Facility:
Name:
University Hospital Tübingen
Address:
City:
Tübingen
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Andreas Hartkopf, MD
Facility:
Name:
University Hospital Ulm
Address:
City:
Ulm
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Wolfgang Janni, MD
Facility:
Name:
University Hospital Würzburg
Address:
City:
Würzburg
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Achim Wöckel, MD
Contact backup:
Last name:
Jessica Salmen, MD
Start date:
June 12, 2017
Completion date:
December 31, 2030
Lead sponsor:
Agency:
German Cancer Research Center
Agency class:
Other
Collaborator:
Agency:
University Hospital Heidelberg
Agency class:
Other
Source:
German Cancer Research Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05652569
