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CATCH study


Overview

  • The CATCH study is open to breast cancer patients whose disease is advanced or metastatic. This means that the cancer has already spread to other organs.
  • The characteristics of cancer cells in a metastasis are comprehensively analyzed using the latest methods.
  • The aim is to identify individually tailored treatment options based on molecular changes in the tumor. 

Study status: The study is currently enrolling patients (recruitment open).

Breast cancer arises due to changes in the DNA of cells in the mammary glands. These cancerous cells have different characteristics when compared to normal, healthy cells.

Some of these molecular changes can be specifically targeted for treatment. Medications that target these changes are called targeted cancer drugs. These drugs preferentially target altered cancer cells and largely spare the body’s healthy cells.

In breast cancer, as well as in other types of cancer, the patterns of molecular changes can vary considerably from person to person, as well as from one tumor tissue to another. For this reason, patients often receive different active substances in targeted therapies – even if their clinical situation appears very similar at first glance. 

In the CATCH study, experts are investigating the characteristics of tumor cells in women and men with advanced / metastatic breast cancer. To do this, they are using a modern molecular biology technique known as next-generation sequencing (NGS). This involves analyzing the tumor’s DNA by sequencing many small DNA fragments simultaneously to identify changes relevant to tumor growth.

The aim is to identify targets and so-called biomarkers for targeted therapies that are precisely tailored to the patient’s tumor. This approach is also known as precision oncology. CATCH is a precision oncology study. 

Important to know

As part of the CATCH study, patients undergo molecular biological testing. This involves analyzing the tumor’s DNA. This helps identify suitable medications. Ideally, patients will then receive a personalized treatment recommendation.

The proposed treatment itself does not take place as part of the CATCH study. It can be carried out in various ways:

  • As part of an independent clinical treatment trial.
  • With a drug already approved for the condition.
  • Using a drug approved for a different condition. In this case, coverage of the treatment costs must be clarified individually with the health insurance provider.

Which types of cancer are covered by CATCH?

Patients with advanced / metastatic breast cancer can take part in the CATCH study. They must also meet further criteria to participate, with the most important ones being that:

  • It is possible to take or analyze a fresh sample of the tumor tissue.
  • The patient is healthy enough to take part in the study.

For details of the other requirements for patients to take part in the study, please see the section ‘Who is the study suitable for?’.

CATCH is an abbreviation of the study’s title: “Comprehensive assessment of clinical features and biomarkers to identify patients with advanced or metastatic breast cancer for marker-driven trials in humans”.

The aim is to identify patients with advanced or metastatic breast cancer for whom targeted drugs are a suitable treatment option.

You can read what this means in detail in the next section.

Objectives of the CATCH study

  • To create an individual profile of tumor cell characteristics: Using modern molecular biological methods, the DNA of metastases that have proven resistant to previous therapies is examined. These are particularly significant for the patient’s disease progression.
  • To support the decision to use targeted drugs: Tumor cell characteristics (biomarkers) can influence the course of the disease and are useful for predicting the response of the disease to specific treatments. The discovery and identification of such characteristics is intended to help decide if targeted drugs are a suitable therapy option.
  • To identify patients who might benefit from personalized treatments.
     

Are there any initial results yet?

Data from several hundred study participants has already been analyzed. The findings showed that:

  • Almost one in two patients was able to receive the recommended targeted treatment because suitable, targeted medications were already available for their specific condition.
  • In around a third of the study participants, the targeted medication slowed the progression of the patients’ disease.

Patients can take part in the CATCH study if the following criteria are met:

  • Patients have advanced / metastatic breast cancer – regardless of the breast cancer subtype, the location of the metastases, or any previous treatments.
  • The patient has signed a written informed consent form. For patients under the age of 18, informed consent from a parent or guardian must be provided.
  • The participant’s life expectancy is expected to be more than 6 months.
  • Tumor tissue is readily accessible for the collection of fresh tissue samples prior to the start of a new line of treatment, or there is archived material from a metastasis that is no more than 6 months old.

Patients cannot take part in the study if any of the following criteria apply:

  • One of the above points does not apply.
  • The patient has a serious underlying condition or impairment that prevents participation in the study.

The CATCH study is a:

  • Multicenter study: Patients can participate at all NCT study centers in Germany.
  • Registry study: Scientific data and information about patients is collected by analyzing their tumors. The aim is to develop personalized treatment plans where possible.

Further reading

You can read about the different types of studies, how they differ, and about potential advantages or disadvantages in our overview of clinical trials.

Procedure for patients

Graphic representation of the study procedure. The various steps are explained in more detail below.
Procedure for the CATCH study

(1) Registration and consultation with the study team:

The patient registers at the study center. There, the study doctors assess whether an analysis of the tumor genome would be beneficial.

During the consultation, the patient learns about the study’s objectives, the potential benefits of participation, and whether there are any risks. This provides an opportunity to ask questions about the nature of the study and the procedural steps involved. If patients decide to participate following this meeting, they must provide a written consent form.

Further reading

Where can I find the nearest CATCH study center to check whether I am eligible for the study? The most important information on this can be found in the section ‘Where is the study being conducted’.

(2) Sample collection

A tissue sample that is as recent as possible (taken no more than six months ago) is required for the examination of the tumor tissue.

  • The tissue is usually taken via a biopsy or during an operation. In most cases, this can be done as part of a procedure that is already planned. The attending doctors collect a slightly larger tissue sample than is normally needed, which will then be analyzed within the CATCH study.
  • Once all routine examinations have been completed, a pathologist examines the tissue under a microscope to gather study-specific information. Among other things, they check whether there are enough tumor cells present to ensure that the analysis can be carried out reliably.

In addition, a blood sample is taken. The genetic material from the white blood cells is used as a healthy control sample. This helps to identify changes in the cancer cells that are specific to the tumor. 

(3) Molecular genetic testing

Genetic information (see DNA and RNA) is extracted from the tumor and blood samples and analyzed using modern testing methods.

  • Experts then compare the characteristics of the tumor with those of healthy cells from the same person.
  • This allows molecular changes in the tumor to be identified that may be suitable for targeted therapy.

(4) Interpretation of the results and discussion with specialists

Based on the data obtained and further laboratory tests, potential molecular targets within the tumor are identified. 

A team of experts from various disciplines meets regularly in what is known as a molecular tumor board to discuss and evaluate the results.

  • Those involved include doctors and specialists in bioinformatics, molecular biology, and human genetics.
  • Based on the changes identified (biomarkers), potential targeted medications are ranked and documented in a report.
  • The results help to identify individualized treatments for the patient.

(5) Treatment recommendation 

The study doctor discusses the results and recommendations of the molecular tumor board with the patient during a consultation. Together, they decide on the next steps in treatment.

The proposed treatment can take various forms:

  • As part of an independent clinical trial using new and suitable drugs.
  • Using a medication that is already authorized for the patient’s condition.
  • By using a medication already authorized for another condition (off-label use). 

(6) Follow-up

All patients are monitored after completion of the recommended treatment. 

  • Follow-up examinations may be carried out over a period of up to 10 years.
  • To this end, the attending doctors collect medical data on the condition and further treatment and evaluate the study results.

These are the potential benefits of participating in the CATCH study:

  • Patients can benefit from modern precision oncology approaches. These enable a targeted search for treatment options tailored to the characteristics of the tumor cells and the individual patient’s condition.
  • The individual clinical situation is discussed and assessed by various specialists in a molecular tumor board.
  • Patients could receive a treatment recommendation that is tailored (personalized) to their cancer.
  • Patients can decide in advance whether they wish to be informed about a hereditary predisposition to tumor diseases. If a hereditary predisposition to cancer is found, patients or their family members have the option of receiving genetic counselling to potentially take preventive measures. 

Participating in the CATCH study may also have disadvantages:

  • The sample collection, which usually takes place as part of routine procedures, carries minor risks. These include, for example, post-procedural bleeding or inflammation.
  • One possible outcome of the tests is that the experts may be unable to provide any treatment recommendations due to the nature of the sample, e.g., if it contains too few tumor cells. This may have a negative impact by limiting further treatment options.
  • Despite comprehensive data protection and robust data security, there remains a small residual risk of re-identification. This means that it is possible to identify the patient in question from the genetic data. However, the study team has taken extensive security measures to prevent data leaks.

Further reading

You can read about the benefits of taking part in a clinical trial and whether there may also be disadvantages in the overview text on clinical trials.

Where is the study being conducted?

Patients can take part in the CATCH study via the relevant NCT sites.

The addresses and contact details of the study centers are:

Augsburg
Augsburg University Hospital | 
Department of Obstetrics and Gynecology
Prof. Dr. Nina Ditsch
Tel.: 0821 400 2208
Email: studien.gyn-at-uk-augsburg.de 

Berlin
Charité – Universitätsmedizin Berlin |
Department of Gynecology including Breast Centre CCM/CBF
Prof. Dr. med. Jens-Uwe Blohmer
Tel: 030 450 664485
Email: brustzentrum-studienzentrum-at-charite.de 

Dresden
Carl Gustav Carus University Hospital at TU Dresden | 
Department of Obstetrics and Gynecology
Prof. Dr. med. Pauline Wimberger
Tel.: 0351 458 4223
Email: studiensekretariat.gyn-at-ukdd.de 

Erlangen
Friedrich-Alexander University of Erlangen-Nuremberg, 
Erlangen University Hospital | Department of Obstetrics and Gynecology
Prof. Dr. Peter Fasching
Tel: 09131 85 33572
Email: fk-studienzentrale-at-uk-erlangen.de 

Essen
University Hospital Essen | 
Department of Internal Medicine (Tumor Research), 
NCT West Campus Essen
PD Dr. Anja Welt
Tel. 0201 723 85140
Email: studienkoordination.NCT-at-uk-essen.de 

Heidelberg
National Centre for Tumor Diseases (NCT) Heidelberg
Prof. Dr. Andreas Schneeweiss
Tel.: 06221 56 5959
Email: Patientenzentrum2.NCT-at-med.uni-heidelberg.de

Cologne
University Hospital Cologne | 
Department of Obstetrics and Gynecology
PD Dr. Wolfram Malter
Tel.: 0221 478 37567
Email: frauenklinik-studienzentrale-at-uk-koeln.de

Regensburg
University of Regensburg at Caritas Hospital St. Josef |
Department of Gynecology and Obstetrics
PD Dr. Stephan Seitz
Tel: 0941 782 7512
Email: FHK-Studienzentrum-at-csj.de

Stuttgart
Robert Bosch Hospital Stuttgart | 
Department of Gynecology and Obstetrics,
Robert Bosch Centre for Tumor Diseases
Prof. Dr. Matthias Schwab
Tel: 0711 8101 7761
Email: NCT-Studienzentrale-at-rbk.de 

Tübingen
Tübingen University Hospital | 
Department of Women’s Health
Prof. Dr. Andreas Hartkopf
Email: studienzentrale.fr-at-med.uni-tuebingen.de 

Ulm
Ulm University Hospital | 
Department of Obstetrics and Gynecology
Prof. Dr. Wolfgang Janni
Tel. 0731 500 58529
Email: studienzentrale.ufk-at-uniklink-ulm.de 

Würzburg
University Hospital Würzburg | 
Department of Obstetrics and Gynecology
Prof. Dr. Achim Wöckel
Email: studien_FK@ukw.de

The participating study centers of the NCT, along with their contact details, can also be found on the NCT Heidelberg study website.

What costs will participants incur?

Participation in the study is free of charge for patients. However, you will not receive any compensation for your time and effort. 

If you have any questions about the funding of the study, you can ask the study team, for example, during the initial consultation.

How many participants will the study accept? Where are there still places available?

You can find out whether participation is possible by contacting the respective study centers.

If you are interested in taking part in the CATCH study, patients or their attending doctors can send relevant medical documents by post or email to the nearest NCT study center. These include:

  • the latest medical report
  • results from the tissue examination and imaging studies
  • surgical report
  • tumor board recommendation
  • contact details of the patient including current telephone number
  • referral form

At the study center, the study doctors will assess whether participation is possible and whether the patient could benefit from it. If this is the case, the patient will be contacted by the study team.


The CATCH trial is supported by representatives from the following patient organizations:

Scientific publications (selection)

Hlevnjak, M., Heublein, S., Thewes, et al. (2025). Delivering precision oncology in metastatic breast cancer: Clinical impact of comprehensive genomic profiling – The CATCH experience. International Journal of Cancer, 10.1002/ijc.70208. doi.org/10.1002/ijc.70208 

Hlevnjak, M., Schulze, M., Elgaafary, S., et al (2021). CATCH: A Prospective Precision Oncology Trial in Metastatic Breast Cancer. JCO Precision Oncology, 5, PO.20.00248. doi.org/10.1200/PO.20.00248


This study description was prepared by authors from the Cancer Information Service, under the direction of Dr. S. Weg-Remers, based on the study documentation.