The purpose of this trial is to investigate the difference in late radiation morbidity between partial breast irradiation and whole breast irradiation given to women operated on with breast conservation surgery for early breast cancer with a low risk of local recurrence.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
882
40 Gy/15 fractions, 3 weeks
40 Gy/15 fractions, 3 weeks
The Danish Breast Cancer Cooperative Group
Copenhagen, Copenhagen Ø, Denmark
Grade 2 and/or 3 fibrosis after radiotherapy
Time frame: 3 years
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
morbidity and recurrences
Time frame: 10 years
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