Study on Establishing a Research Network to Provide the Best Possible Care for Breast Cancer Patients Through Biomarker Testing

Breast cancer (mammary carcinoma) is one of the most common types of cancer in women, but it can also affect men. It is a malignant disease of the mammary gland tissue characterized by the uncontrolled proliferation of mammary gland cells. Treatment of the disease depends on numerous factors, such as the patient’s overall health, the stage of the disease, the tumor’s growth rate (Ki-67 index), the presence of detectable hormone receptors on the surface of the cancer cells (estrogen receptor-positive, progesterone receptor-positive), and the increased presence of HER2 receptors on the cells (HER2-positive). To determine these and other characteristics of the cancer cells, a tissue sample (biopsy) must be taken and the tissue examined. This is all the more important because new therapies are usually targeted, meaning they can specifically attack certain structures within the cancer cells. This is a major advantage over “standard chemotherapy,” which attacks not only tumor cells but also other rapidly dividing cells in the body and therefore generally causes significantly more side effects than targeted therapy. Ideally, the characteristics of the tissue sample can provide clues as to whether a therapy is working well or could work well. Such biological characteristics are called biomarkers. However, further developments in the field of biomarkers could still be helpful. For example, new techniques also make it possible to obtain suitable biomarkers directly from the blood, so that in the future, taking a tissue sample—such as from a metastasis—may become unnecessary.

The PRAEGNANT study now aims to identify additional blood-based biomarkers, examining various techniques and types of biomarkers in the process. The study is purely observational, and patients are only required to provide blood samples and, if necessary, tissue samples from the tumor or metastases. It includes both patients with early-stage breast cancer who have not yet developed metastases and patients with advanced breast cancer at various stages of treatment. The study is therefore not testing a new treatment method.

Women and men who have been diagnosed with breast cancer and are at least 18 years old are eligible to participate in the study. The disease can be at any stage (1–4). There are no restrictions regarding past or ongoing treatments. The only exclusion criterion may be poor health or another serious illness that prevents patients from attending follow-up appointments regularly.