Study to Evaluate PITX2 (Genetic Marker) for Predicting the Probability of Recurrence Following Neoadjuvant Chemotherapy in Hormone-Receptor-Positive Breast Cancer

The treatment of breast cancer (mammary carcinoma) depends on the stage of the disease. If chemotherapy is necessary before surgery, anthracyclines and taxanes are generally used as established standard treatments. The goal of this multi-stage treatment is to cure the disease, including preventing a recurrence. To achieve this, targeted tests are conducted—including on tumor cells—to determine whether certain characteristics increase the risk of the disease returning. This can also be influenced by the choice of chemotherapy. These include, for example, alterations in the PITX2 gene within the cancer cells.

The goal of the P4 study is to examine routinely collected tissue and blood samples to determine whether a specific, transient change in the genetic material (methylation of the PITX2 gene) can predict the risk of recurrence following anthracycline-based chemotherapy. Participation in the study does not provide any immediate benefit to the patient herself. However, the study’s results could help ensure that patients receive more targeted treatment in the future. No new treatment is being tested.

Women aged 18 and older with hormone receptor-positive, HER2-negative breast cancer and a high-risk profile who require neoadjuvant chemotherapy prior to surgery are eligible to participate in the study. An anthracycline-based chemotherapy regimen must be planned, which corresponds to standard therapy. The cancer must not be a recurrence. During standard treatment, additional data collection and follow-up will take place.