Testing a New Diagnostic Method for Assessing the Response to (Neoadjuvant) Drug Therapy for Breast Cancer

Breast cancer (mammary carcinoma) is a malignant disease of the mammary gland tissue characterized by the uncontrolled proliferation of mammary gland cells. In most cases, the tumor has not yet formed secondary tumors (metastases) in the body at the time of diagnosis. This corresponds to stages 1 through 3 (locally confined to locally advanced), in which the goal is to achieve a cure. The best approach for this has been established as a combination of initial chemotherapy (neoadjuvant) followed by breast surgery. Subsequently, depending on the presence of risk factors, further therapy (adjuvant) is administered. Neoadjuvant therapy has a significant impact on the chances of a cure. If this therapy is not optimally effective, the chances of a cure decrease. Since the response to therapy can vary from patient to patient and is currently unpredictable, it would be very helpful to develop a biomarker capable of rapidly analyzing the response to therapy.

The goal of the BREVITY-02 study is to evaluate the response to neoadjuvant therapy using a so-called “RNA disruption assay” (RDA) measurement of the tumor tissue. To this end, small samples of tumor tissue will be collected from participants approximately 35 days (± 4 days) and 55 days (± 5 days) after the start of neoadjuvant therapy via core needle biopsy and analyzed using the “RNA disruption assay.” This assay can demonstrate the cell-damaging effect of the treatment in the tumor tissue by assessing the extent to which the metabolism of the tumor cells is impaired by chemotherapy. The greater the damage, the more reliably the cells are destroyed. After surgery, the patients are evaluated to determine whether they have achieved complete remission (no more detectable cancer cells). This study will initially be conducted with 80 patients. Based on this, a range of measurement values will be established to determine at which result of the RNA test the effect of chemotherapy can be presumed to be successful (responder) and at which it is not (non-responder). In the second phase, this range of values will be evaluated in 454 additional patients.

The type of neoadjuvant therapy is selected by the treating physicians. If it becomes apparent that the therapy is not working (this assessment is not based on the results of the RNA test, but on established standard values) and must be changed, a repeat core needle biopsy and RDA analysis will be performed after 2–3 weeks. At the discretion of the treating physicians, participants may also receive follow-up treatment after surgery. However, this decision is made independently of the results of the “RNA Disruption Assay” measurement.

The study is not blinded, meaning that both the medical staff and the patient know which medications are being taken. The key factor being measured is whether or not the tumor was completely regressed at the time of surgery; this is compared with the RDA assessment.

Female patients aged 18 and older with stage 1 through 3 breast cancer who have been recommended for neoadjuvant therapy and surgery are eligible to participate in this study.