CATCHRecruiting

CATCH Study: A Personalized Approach to Breast Cancer

Gender
Women and men
Age
14–100 years
Trial type
Observational
Line of therapy
all
Phase

What is this trial about?

When breast cancer is diagnosed, testing the tumor tissue for specific genetic changes (mutations) has become standard practice. Testing for additional mutations could improve our understanding of the disease and enable personalized, targeted treatments. The goal of the CATCH study is to investigate the effect of comprehensive molecular genetic testing in patients with advanced or metastatic breast cancer. Women and men aged 14 and older who have advanced or metastatic breast cancer are eligible to participate.

Trial flow

Requirements

Diagnosis: breast cancer

Age: 14 years and older

Line of therapy: Unabhängig von Therapielinie

Key inclusion criteria: advanced or metastatic disease

Allocation

Einarmige Studie

Treatment

molecular analysis of metastatic tissue

Follow-up

36 months

Detailed description

Cancer develops as a result of abnormal changes in a cell’s genetic material, known as mutations. These mutations vary across different types of cancer, which is why the treatment of different tumor types also differs. Even within a single tumor type, such as breast cancer, each tumor exhibits a unique pattern of mutations that can vary from patient to patient. Furthermore, these patterns can change as the disease progresses. To better understand the individual disease and treat it more effectively, it is helpful to identify the genetic patterns of the cancer cells. With this knowledge, the right drugs can be specifically selected and combined, thereby further improving cancer treatment in the future.

Currently, after a diagnosis of breast cancer, the first step is to determine how far the cancer has spread throughout the body—a process known as staging. In addition, a tissue sample is taken from the tumor and examined for specific characteristics. Molecular markers such as HER2 and hormone receptors are of particular importance in breast cancer. These markers or receptors, to which specific drugs can bind and thus influence cancer growth, enable targeted treatment. While individual genetic analyses are already part of standard procedures, more comprehensive genetic analyses (gene sequencing)—which can simultaneously examine several hundred changes in a cell’s genetic material (DNA)—are not yet standard practice. Tumor DNA sequencing covers a broad spectrum and also includes proteins and other molecules in the body. This test is performed on tissue samples from disseminated cancer cells (metastases).

The goal of the CATCH study is to conduct the most comprehensive genetic analysis possible of the tumor tissue in order to identify individual characteristics of the cancer. To do this, the genetic material of the tumor cells is compared with that of healthy body cells, which are obtained, for example, from a blood sample. Tissue samples are taken from the patients’ metastases, and a genetic profile is created for each study participant. The results are then evaluated during a discussion session involving experts from various disciplines (an interdisciplinary molecular tumor board), and new treatment options are explored. Depending on the genetic change (mutation), this may be a proven standard therapy or a drug that is actually approved for the treatment of other diseases but could also be promising for the individual’s specific form of breast cancer (off-label therapy). In addition, based on the test results, patients may be eligible for experimental treatments as part of ongoing studies. The CATCH study is a purely observational study in which a comprehensive molecular genetic analysis of the breast cancer cells is performed. The study also examines how many patients were able to be offered additional treatment options based on the comprehensive genetic analysis. Patient data will be documented for the study for at least 3 years through regular follow-up visits (every 3 months).

Women and men aged 14 and older who have locally advanced or metastatic breast cancer are eligible to participate in the study.

Facts

  1. Disease: Breast cancer
  2. Cancer characteristics: advanced or metastatic
  3. What the study investigates: comprehensive genetic analysis of metastatic tissue and comparison with healthy genetic material
  4. Study objective: to improve treatment options and understanding of advanced and metastatic breast cancer.
  5. How long will the study last: at least 3 years
  6. Study characteristics: observational; possibility of additional treatment options based on the results of the molecular analysis

Trial sites

13 trial sites in Germany are listed. Find a site near you.

  • Universitätsklinikum Augsburg

    Stenglinstraße 2, 86156 Augsburg

    Recruiting
  • Charité – Universitätsmedizin Berlin

    Berlin

    Recruiting
  • Universitätsklinikum Carl Gustav Carus Dresden

    Fetscherstraße 74, 01307 Dresden

    Recruiting
  • Zentrum für Evidenzbasierte Gesundheitsversorgung

    Dresden

    Recruiting
  • Universitätsklinikum Erlangen

    Maximiliansplatz 2, 91054 Erlangen

    Recruiting
  • Universitätsklinikum Essen

    Hufelandstraße 55, 45147 Essen

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT05652569) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.