Study of Preventive Radiation to the Opposite Breast in Women Aged 30 to 70 with BRCA1, BRCA2, or PALB2 Mutations and Breast Cancer

What this Trial Is About

Breast cancer is the most common cancer among women worldwide and carries a high risk of death. About 5% to 10% of breast cancers are inherited, mostly linked to mutations in BRCA1, BRCA2, and PALB2 genes. Women with these mutations have a high lifetime risk of breast cancer and a significantly increased risk of developing cancer in the opposite breast after an initial diagnosis. While removal of the opposite breast is often recommended to reduce this risk, many women decline due to concerns about surgery and its effects on body image and sexuality. This trial compares two approaches for women with BRCA1, BRCA2, or PALB2 mutations who have early-stage breast cancer. One group receives standard local treatment without radiation to the opposite breast, while the other group receives standard treatment plus radiation to the opposite breast. Radiation is delivered daily, five days a week, for 5 to 6 weeks at a total dose of 45-50 Gy. The goal is to see if radiation can reduce the risk of cancer developing in the opposite breast, potentially offering an alternative to surgery. Participants will be followed for up to 10 years to monitor for development of cancer in the opposite breast, overall survival, local recurrences, distant metastasis, and any side effects from radiation. Follow-up visits occur every 3 to 6 months initially, including imaging and clinical evaluations. Safety is closely monitored, especially during the first 3 months after radiation starts, with long-term effects tracked throughout the study. The study aims to provide important information about the potential role of radiation to prevent new breast cancers in this high-risk group.

Prophylactic Irradiation to the Contralateral Breast for BCAs Patients