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CATCH


Overview

  • Study title: CATCH: Comprehensive assessment of clinical features and biomarkers to identify patients with advanced or metastatic breast cancer for marker driven trials in humans
  • Study design: Prospective, multicentre, observational study
  • Study participants: Patients with locally advanced or metastasised breast cancer at diagnosis or at the time of disease progression
  • Study objective: Individual genotype and biomarker profile of the prognostically leading lesion and derivation of individual treatment recommendations

Clinical.trials.gov-Identifier / NCT-ID: NCT05652569

Study status: Currently recruiting

CATCH (Comprehensive assessment of clinical features and biomarkers to identify patients with advanced or metastatic breast cancer for marker driven trials in humans) is a multicentre observational study.

The study enrols men and women with metastatic or locally advanced, inoperable breast cancer, across all subgroups at all time points.

CATCH employs modern molecular biology techniques to comprehensively analyse the individual genetic material of metastases in breast cancer patients. Blood and tissue samples are collected for this purpose. Potential molecular targets are identified, on the basis of which the patients are offered targeted therapies - such as participation in further clinical trials.

 

Important to know: 

Drug treatment based on these recommendations are no longer part of CATCH. Coverage of therapy costs may need to be clarified individually with the patients’ health insurance.

The pilot phase of the CATCH study has shown that the progression of the disease could be delayed in approximately one third of patients who received targeted therapies based on the results of molecular diagnostics. Accordingly, there is also a chance of a favourable course of the disease for patients who already have received multiple treatments before.

The insights gained from the study will also contribute to a better understanding of the biology of advanced breast cancer. On this basis, diagnostic procedures and new targeted substances can be further developed.

The aim is to integrate this innovative diagnostic approach into standard care so that a broader patient population may benefit from it in the future.

Cancer patients can sign up for the CATCH study via the participating Comprehensive Cancer Centres at the NCT sites. Registration is carried out by the oncologist in charge or the patient herself. 

Details of the participating NCT study centres and their contact information can be found on the NCT Heidelberg study website.

CATCH is a multicentre, single-arm diagnostic study on advanced breast cancer designed at NCT Heidelberg. As part of the study, clinicians use molecular analysis data of the prognostically leading tumour lesion and blood samples to derive personalised and targeted therapy recommendations. 

CATCH provides comprehensive molecular genetic diagnostics using standardised and quality-assured testing methods. 

  • Whole genome sequencing (WGS) or whole exome sequencing (WES)
  • RNA sequencing
  • Validation of selected therapeutic target structures

  • Use of tissue and blood samples that required for the above analyses in accompanying scientific programmes. These may include, e.g., functional analysis of driver mutations, investigation of therapy resistance mechanisms, or immunoprofiling.

     

Aims of CATCH

  • To generate an individual genotype and biomarker profile of the prognostically leading lesion in patients with locally advanced (including local recurrence) or metastatic breast cancer
  • To identify prognostic and predictive, therapy-relevant driver mutations, and biomarkers to support treatment decisions on targeted drugs
  • To identify patients eligible for ongoing, molecularly stratified clinical trials
  • To assess participants‘ quality of life
  • To test innovative diagnostic procedures prior to their integration into standard care

Inclusion criteria

  • Female and male breast cancer patients with locally advanced or metastatic breast cancer (irrespective of clinical parameters such as TNM classification, tumour subtypes, or number of prior therapy lines)
  • Age ≥ 18 years; younger patients may be enrolled with written consent from a parent or legal guardian.
  • The patient provides written informed consent and is capable to signing it.
  • The life expectancy of the participating person is > 6 months.
  • The patient's performance status according to the Eastern Cooperative Oncology Group (ECOG) is ≤ 2.
  • Availability of a punchable or surgically accessible lesion to obtain fresh tissue prior to initiation of the next line of therapy
     

Exclusion criteria

  • The patient is not suitable for the study according to the above criteria.
  • Early-stage breast cancer has been diagnosed.
  • It is not feasible to obtain a fresh tissue sample at the time of metastasis or disease progression, e.g., due to lesion location or patient‘s health status.
  • Any physical or mental condition, or severe comorbidities, that would impede adequate patient cooperation
  • The patient has not signed the declaration of consent or has withdrawn consent.


1. Contacting and introducing the patient

The attending physician registers the patient for the study. Alternatively, patients may register themselves. 

The following documents should be sent to one of the participating study centres near the patient`s place of residence: a recent doctor's letter, histology report, CT/MRI findings, surgical report, tumour board recommendation, the patient`s contact details (including telephone number), and a referral form. 

During an appointment, the patient is informed by the study physician. A decision regarding participation is made, followed by signing of the written informed consent form.
 

2. Sampling

Tissue sample: High-throughput sequencing requires particularly gently extracted DNA and RNA. Therefore, the tumour material must be deep-frozen immediately after removal.

Since tumour biology can change during the course of the disease, the tissue sample should be as recent as possible. It may be obtained fresh via biopsy or during surgery. Only in exceptional cases, formalin-fixed, paraffin-embedded (FFPE) tissue can be used. To ensure reliable sequencing, the sample must contain at least 20% tumour cells. A pathologist examines the tissue under a microscope and determines the tumour cell content along with other relevant parameters.

Blood sample: To identify tumour-specific alterations, a healthy comparison sample is required. This also allows the detection of hereditary (germline) changes predisposing to cancer. DNA is extracted from leukocytes obtained from a blood sample. Depending on individual requirements, further blood samples may be needed over the course of treatment to monitor markers for disease progression, for example, to evaluate the tumour's response to therapy.
 

3. Molecular profiling

In the sample processing laboratory at NCT Heidelberg, DNA and RNA are extracted from tumour tissue, and DNA is isolated from blood samples. Sequencing is carried out at the Next Generation Sequencing Core Facility at DKFZ.

At the Computational Oncology Group within the Molecular Precision Oncology Programme of NCT Heidelberg, experts compare sequencing results from tumour and normal tissue to identify tumour-specific alterations.

All steps of sample preparation, molecular profiling, and data analysis are performed under strict quality control at the German Cancer Research Centre (DKFZ).
 

4. Clinical curation and data interpretation

Based on the molecular data collected and any additional laboratory analyses, such as preclinical testing of potential active substances, scientists identify target structures for drugs and assess their chances of success.
 

5. Molecular tumour board

Therapy-relevant alterations are discussed in the Molecular Tumour Board — a multidisciplinary panel comprising specialists in oncology, bioinformatics, molecular biology, pathology, and human genetics.
The board generates a prioritised list of potential targeted therapies and documents the recommendations in a formal report.
 

6. Notification of results, treatment recommendation

A study physician reviews the tumour board report with the patient, explaining potential treatment options. The report is also forwarded to the attending oncologist. 
 

7. Treatment, possibly inclusion in a clinical trial

The treatment is carried out with the patient's consent and at the discretion of the treating oncologist or study physician, in one of the following contexts:

  1. Within independent clinical trials (AMG Phase I–III studies) for investigational drugs
  2. Within the authorised indication
  3. As off-label use involving drugs authorised for a different indication

In the case of off-label use, efforts are made to secure cost coverage from the patient’s health insurance provider.
 

8. Follow-up

Follow-up visits are arranged according to the needs of the study participants — e.g. for symptom evaluation — at intervals of at least three months. Follow-up may continue for up to 10 years, unless the patient dies or withdraws from the study earlier.

In addition to clinical information on physical condition, disease status and current diagnostics or therapy, various quality-of-life and other patient-reported outcomes (PROs) of the study participants are assessed using appropriate questionnaires.

The attending physician or the patient herself sends a current doctor's letter, histology, CT/MRI findings, surgical report, tumour board recommendation, contact details of the patient with telephone number, and a referral form by post to the address below or to a study centre close to her place of residence:
 

NCT Heidelberg

Patient Centre 2
Im Neuenheimer Feld 460
69120 Heidelberg

Phone: 06221 56-5959
Fax: 06221 56-5320
E-mail: Patientenzentrum2.NCT-at-med.uni-heidelberg.de

Contact details for other NCT study centres can be found on the study website.

The study is supported by patient experts from MammaMia, Brustkrebs Deutschland e.V. and the PATH Biobank.

 

Coordinating Principal Investigator

Prof Andreas Schneeweiss, MD
Head of the Gynaecological Oncology Section
Heidelberg University Hospital