The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial
All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.
⁃ Female patient \>=60 years
⁃ Primary tumour characteristics by conventional histopathology
• unilateral and unifocal non-lobular histology grade 1-2
• maximum microscopic size \<=20mm
• node negative determined by sentinel node or axillary lymph node dissection
• estrogen receptor \>=10% positive
• HER2 negative (by IHC and/or in situ hybridization)
• resection margin \>=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer
⁃ Surgical type is breast conservation
⁃ Performance status ECOG 0-2
⁃ No evidence of distant metastasis