The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.
The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity. The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
976
standard fractionated radiotherapy 50 Gy/25 fractions
hypofractionated radiotherapy 40 Gy/15 fractions
The Danish Breast Cancer Cooperative Group
Copenhagen, Denmark
Grade 2 or 3 fibrosis 3 years after radiotherapy
Time frame: 3 years
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time frame: 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.