Partial Breast Versus Whole Breast Irradiation to Women ≥ 60 Years Operated With Breast Conservation for Early Breast Cancer: a Randomized Fase II Trial
The study is 2-armed. In both treatment arms the radiotherapy consists of 40 Gy in 15
fractions, 2.67 Gy per fraction. The primary endpoint in the trial is late radiation
morbidity evaluated as fibrosis, secondary endpoints are other types of late morbidity, rate
of local recurrence and an attempt to establish a genetic risk profile for development of
late radiation morbidity.
The hypothesis is that women operated with breast conservation for a breast carcinoma with
low risk of local recurrence can be offered partial breast irradiation without risking more
late radiation morbidity compared to whole breast irradiation.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Grade 2 and/or 3 fibrosis after radiotherapy
Lars Stenbygaard, MD
Denmark: The Radiotherapy Committee under The Danish Breast Cancer Cooperative Group
DBCG PBI protocol