NU UP19B05 - Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (Radcomp) Consortium Trial

Side Effects of Breast Cancer Treatment Affect Millions of Americans. Nearly 3 million women are living with breast cancer in the United States (US). (American Cancer Society 2014, Hayat 2007) Radiotherapy plays a major role in the treatment of breast cancers. Because of incidental radiation to the heart, radiotherapy carries increased risks of cardiovascular morbidity and mortality; survivors who receive radiotherapy have at least a two-fold increased risk of cardiovascular death. (Darby 2013) Thus, success of cancer therapy has led to survivorship burden. Patients live longer but suffer from toxic consequences of treatment. Proton therapy, by reducing the volume of heart and lungs exposed to radiation in the treatment of breast cancer, has the potential to lessen the morbidity of radiation therapy compared to photon therapy, now the predominant radiation treatment in the US. However, proton therapy is more expensive and has yet to be shown to improve health outcomes for patients with breast cancer.