Study of Genetic Changes in Metastatic Breast Cancer to Develop Personalized Treatments

Breast cancer is a malignant disease of the breast tissue in which cells multiply uncontrollably. In advanced stages, it can lead to the formation of secondary tumors (metastases). Treatment then depends on various factors. These include the patient’s overall health, the biological characteristics of the tumor—such as hormone receptor status (sensitivity to the body’s own hormones), HER2 status (a protein on the cell surface that can influence tumor growth), and genetic changes (mutations).

The goal of the AURORA study is to comprehensively analyze the genetic changes in breast cancer tumors. This is not a drug trial. Instead, tissue samples (biopsies) from metastases, existing tumor tissue obtained at the time of the initial diagnosis, and blood samples are examined. Modern molecular analysis methods are used, which can detect a broad spectrum of genetic alterations. In particular, the study examines how tumors undergo genetic changes between the initial diagnosis and the development of metastases, and which changes may be associated with a response to therapy or the development of resistance. In addition, the aim is to identify biomarkers. Biomarkers are measurable biological characteristics that can provide indications of whether a specific therapy is effective. If genetic alterations are found in patients for which targeted therapies are already being researched, participation in appropriate clinical trials may be facilitated. Tissue is collected via biopsy, which is a minimally invasive procedure. Blood samples are also collected at regular intervals.

Patients aged 18 and older with locally advanced or metastatic breast cancer are eligible to participate. According to the current study protocol, the disease must fall into one of the following categories: triple-negative breast cancer (TNBC), invasive lobular carcinoma (ILC), or a recurrence more than 10 years after the initial diagnosis. It is also important that patients have received no more than one course of systemic therapy for the metastatic disease to date, and that a tissue sample from a metastasis as well as blood samples can be collected. A prerequisite is that the patient’s general condition is sufficient to undergo the planned examinations.