Study Using MRI and Pathology to Choose Women 50 With Early Breast Cancer Who May Skip Post-Surgery Radiotherapy An International Two-Arm Study Comparing Radiotherapy Omission versus Standard Treatment

What this Trial Is About

Researchers are studying whether Magnetic Resonance Imaging MRI results can help identify women with early breast cancer who might safely skip radiotherapy after surgery without increasing the chance of cancer returning in the same breast. This international follow-up study, called PROSPECTIVE, builds on earlier research suggesting that MRI combined with pathology can select patients with low-risk breast cancer who may not need radiotherapy. The study also looks at patient quality of life, fear of cancer recurrence, and health economics related to omitting radiotherapy. Participants are divided into two groups based on their MRI and pathology results before surgery. Those with minimal or mild breast changes on MRI and meeting certain pathology criteria may be assigned to Arm A, where radiotherapy is omitted. Arm A is further divided into low-risk and high-risk groups based on cancer grade and HER2 status. Participants not meeting these criteria, or those preferring standard care, receive radiotherapy as part of Arm B. Treatment decisions consider MRI findings, pathology details, and patient or clinical team preferences. During the study, participants undergo regular follow-up for up to 10 years to monitor if cancer returns in the same breast or elsewhere. Researchers assess outcomes including invasive recurrence rates, quality of life, fear of recurrence, mental health, and survival. Patient-reported outcomes are collected at multiple timepoints up to five years post-surgery. The long-term follow-up helps evaluate the safety and impact of omitting radiotherapy in selected patients with early breast cancer.

Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)