A registry study to collect data on the current status of breast cancer treatments for the purpose of long-term treatment optimization

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 breast tissue characterized by the uncontrolled proliferation of breast cells. Treatment of the disease depends on numerous factors, such as the person’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 expression of the HER2 protein on the cells (HER2-positive). It is also crucial to determine the stage of the tumor (stages 1–4) and how far it has spread throughout the body (metastases). The standard treatment depends on all of these factors. In early stages, a combination of surgery, radiation therapy, and drug therapy is often used. In advanced breast cancer, the focus is on systemic therapy—that is, treatment with drugs that act throughout the body and are intended to slow or stop the growth or progression of cancer cells. These include chemotherapy, anti-hormone therapy, and targeted therapies. Since there are many different forms of the disease and treatment options, it is important to compare the various subgroups with one another in order to further improve treatment for patients. An important aspect of this is that there are ever-improving ways to examine the specific characteristics of the disease (tumor characteristics), which can vary from patient to patient. This is crucial for developing a therapy that is as targeted and individually tailored (personalized) as possible.

The OPAL study is being conducted at various sites in Germany. For the study, data on tumor characteristics, previous treatments, and the general health status of the study participants are being collected. Throughout the course of the study—which will last a maximum of five years—all further treatments and their outcomes will be documented. A key component of the study is the assessment of the study participants’ health-related quality of life. This data is intended to help improve future treatment strategies. Study participants can enter some of their data independently via an online platform (portal). Within the study, they are divided into different groups based on the specific nature of their disease to enable comparisons.

Women and men aged 18 and older who have early-stage (stages 1–3) or advanced (stage 4) breast cancer are eligible to participate in the OPAL study. No specific type of breast cancer is excluded from participation. However, participants must be at the start of their first systemic therapy. Patients who have already received systemic therapy for breast cancer are not eligible to participate. Previous non-systemic treatment, such as surgery or radiation therapy, is permitted and will be documented in the portal.