Short summary

In this prospective biomarker study, we wish to explore and validate the clinical utility of selected biomarkers to stratify patients to the optimal treatment strategy of local advanced breast cancer. Breast cancer is a very common cancer worldwide and mostly curable. However, patients suffer from side and late effects from extensive curative treatment strategy. There is a current need for biomarkers with prognostic and predictive value to improve breast cancer care.

Rationale

Breast cancer is a very common form of cancer among Western women, with approximately 5,000 new cases in Denmark each year. Over 90% of cases can be cured, primarily through surgery. High-risk patients are offered medical treatment before surgery to improve survival and surgical outcomes. Some patients achieve complete response, meaning no visible tumor remains at time of surgery. Significant advances in treatment now include hormone therapy, chemotherapy, targeted antibody therapy, and immunotherapy, which increase the risk of side and late effects. Regular breast MRIs monitor treatment effectiveness but are resource-intensive, expensive, and require a certain tumor size to be visible. More sensitive methods are needed to ensure optimal treatment and avoid ineffective treatments with unnecessary side and late effects. Blood biomarkers have shown great potential for monitoring treatment effects. Biomarkers are signaling molecules measurable in blood that provide information about a specific condition or disease. Studies have identified three specific biomarkers linked to cancer and its burden: 1) Circulating tumor DNA (ctDNA), a byproduct of the tumor. 2) Natural killer (NK) cell activity, part of the immune system. 3) RNA molecules which bind to specific proteins in the blood. These biomarkers allow for easy, quick, and repeatable blood tests to monitor disease activity throughout treatment. Initial studies are underway to assess the effectiveness of NK cell activity and RNA molecules as biomarkers. This study aims to validate the clinical usefulness of ctDNA, NK cell activity, and RNA molecules as biomarkers in the preoperative treatment of breast cancer.

Description of the cohort

Newly diagnosed patients with local or local advanced breast cancer eligible for preoperative medical treatment. Patients are included from the Department of Oncology, Vejle Hospital, upon their first visit.

Data and biological material

Blood samples. Clinical and demographic data.

Collaborating researchers and departments

Department of Oncology, Vejle Hospital

• Else Maae, MD, PhD
• Torben Frøstrup Hansen, Professor, MD, PhD
• Signe Timm, Biostatistician, PhD

Department of Clinical Biochemistry

• Line Nederby, Molecular Biologist, PhD