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Intervention protocol 03a

Partial breast irradiation (PBI) - a randomized trial from the Danish Breast Cancer Group (DBCG)

Objectives Partial breast irradiation (PBI) is a new approach to postoperative radiotherapy, where only the tumour bed with a small margin around is irradiated. Several methods for PBI have been used in phase I/II studies, and several phase III trials are now accruing. The most recent phase III PBI study uses 40 Gy in 15 fractions. The aim of our protocol is to study PBI in women > 60 years after radical surgery for low-risk early breast cancer (i.e. pT1, pN0, grade I, estrogen receptor positive, HER2 negative)
Study outline (intervention) Patients will be prospectively randomized to 40 Gy in 15 fractions and either PBI or whole breast irradiation. The study will start Oct. 2008 and the aim is to randomize 600 patients in 3 years and follow them for at least another 3 years. All oncological departments with radiotherapy facilities in Denmark will participate. Morbidity related to normal tissue in the breast, heart, lung, thorax wall and ribs are the primary outcome measures. Secondary endpoints include loco-regional control, disease free survival and overall survival. Morbidity will be scored by the DBCG morbidity system. Prognostic and predictive statistical models including volumetric, dosimetric, clinical and biological risk factors as wells radiobiological parameter estimates will be used to allow precise risk estimation in individual patients.
Expected impact Other trials indicate that it is possible to irradiate a smaller volume of the breast and still have an acceptable low LR rate. The smaller irradiated volume is expected to translate into lesser morbidity, which is important, since the therapy is adjuvant and the patients have a long life expectancy. It will also spare the patient 9 treatments and she will thus hopefully be able to recover more quickly.
Linkages with work packages WP 1, 9. Tools from WP1 will be used to obtain knowledge of the tumourbiology within the breast target and the adjacent normal tissues