Non-surgical Approach (Radiation Therapy) for the Treatment of Early Stage Breast Cancer Patients with an Exceptional Response to Neoadjuvant Chemotherapy, NoCUT-BC Trial
This phase II trial compares the effect of non-surgical treatment, radiation therapy, to standard of care (SOC) surgery followed by radiation therapy in treating patients with breast cancer that has not spread beyond the breast and the axillary lymph nodes (early stage) who have had an excellent response to neoadjuvant chemotherapy (NAC). SOC treatment for early stage breast cancer includes chemotherapy given before surgery (neoadjuvant) with the goal of shrinking the tumor. Patients may also receive radiation therapy after surgery as part of SOC treatment. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Surgery may include removal of abnormal tissue or tumor from the breast and a small amount of normal tissue around it (lumpectomy) or removal of the breast or as much of the breast tissue as possible (mastectomy). Non-surgical treatment with radiation therapy may have similar recurrence rates compared to SOC surgery followed by radiation therapy in patients with early stage breast cancer that have responded well to NAC. This study also evaluates the use of circulating tumor deoxyribonucleic acid (ctDNA) to identify any remaining tumor cells after treatment. ctDNA is a type of cell-free DNA that is released by the tumor into the blood. Measuring ctDNA with a data analysis program may be an effective method to determine if tumor cells remain after treatment and to predict complete response after chemotherapy.