Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer
Following breast conservative surgery, patients will be stratified according to the
following prognostic factors using a minimisation technique: age (<70 vs ≥70), HER2 status
(HER2+ vs HER2-), hormonal receptor status (RH+ vs RH-) and lymph node invasion (pN0 vs
Patients will be allocated to receive either standard treatment, hypofractionated treatment
Radiation therapy should be started between 4 and 12 weeks after the last surgery.
Patients treated with standard whole breast irradiation will receive a total dose of 50 Gy
in 25 fractions, 2 Gy per day, 5 days a week. The boost of 16 Gy will be delivered in 8
fractions for all patients after completion of the 50 Gy, without interruption. All patients
will receive one fraction per day, 5 fractions a week.
Patients treated with hypofractionated irradiation will receive a total dose of either 40 Gy
(in 15 fractions, 2.66 Gy per day) or 42.5 Gy (in 16 fractions, 2.65 Gy per day)5 days a
Patients treated with APBI will receive a total dose of 40 Gy in 10 fractions, delivered
twice a day over a time period of 5-7 days. Each daily dose must be separated by 6 hours.
Patients will be followed at 3 and 6 month after the last dose of irradiation, at 12 months
after the date of last surgery and then on a yearly basis during 10 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
rate of local recurrence
To estimate and compare the rate of local recurrence between the experimental and control arms.
Yazid Belkacemi, MD PhD
Henri Mondor Hospital AP-HP, Créteil, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)