Comparison of Two Imaging Methods for Monitoring the Course of Metastatic Breast Cancer

Breast cancer (mammary carcinoma) is a malignant disease of the breast tissue in which cells in the breast multiply uncontrollably. When the tumor spreads beyond the breast and the surrounding lymph nodes to other organs, it is referred to as metastatic breast cancer. At this stage, the disease is generally incurable; however, various effective treatment options are available that are designed to slow the progression of the disease and maintain patients’ quality of life. Imaging tests are performed regularly to determine whether a treatment is working or whether the disease is progressing. The conventional method for this is computed tomography (CT), in which X-rays produce detailed cross-sectional images of the body. FDG-PET/CT is a newer procedure that combines CT with positron emission tomography (PET): In this procedure, a weakly radioactive sugar solution (FDG) is administered; it accumulates preferentially in metabolically active cells, such as cancer cells, thereby making their activity visible. Previous studies suggest that FDG-PET/CT may be able to detect disease progression earlier than conventional CT, potentially allowing follow-up therapy to be initiated sooner if necessary.

The aim of this study is to investigate, in a large-scale comparison, whether FDG-PET/CT-based follow-up is superior to CT-based follow-up in terms of patients’ overall survival. Patients will be randomly assigned to one of two groups. In the study arm, patients will undergo regular FDG-PET/CT scans for follow-up; in the control arm, conventional CT will be used. In both groups, the scans take place at intervals of approximately nine to twelve weeks. In addition, patients regularly complete questionnaires on quality of life. The main objective (primary endpoint) of the study is overall survival at up to 54 months.

Women and men aged 18 and older with newly diagnosed or recurrent metastatic breast cancer who are eligible for first-line drug therapy and regular follow-up using imaging techniques may participate in this study.