342-343 / 1816
BREAST P1:
Multicenter randomized phase III trial comparing protons versus standard photon
radiation therapy in breast cancer with an indication for regional lymph node irradiation in terms
of cardiac toxicity occurrence
n=1310 patients, open for International
participation
5
MAIN OBJECTIVE:
TO ASSESS THE SUPERIORITY OF THE PROTON
LOCOREGIONAL RADIOTHERAPY TO CURRENTLY USED PHOTON-
ELECTRONS 3D-CONFORMAL OR INTENSITY MODULATED RADIATION
THERAPY (IMRT) IN TERMS OF CARDIAC TOXICITY AT 10 YEARS.
SECONDARY
OBJECTIVE S
:
TO SHOW THAT PROTON LOCOREGIONAL RT IS NOT INFERIOR TO CURRENTLY USED PHOTON-
ELECTRONS 3D CONFORMAL RT OR IMRT IN EARLY STAGE BREAST CANCER WITH AN
INDICATION FOR REGIONAL LYMPH NODE IRRADIATION IN TERMS OF LOCAL-REGIONAL
RECURRENCE
TO ASSESS LOCO-REGIONAL ACUTE AND LATE TOXICITIES (RADIODERMATITIS, ARM MOTION AND
FUNCTION, COSMETIC RESULT,
LUNG AND CONTRALATERAL BREAST EVENTS
CANCER RELATED-EVENTS: LOCOREGIONAL RELAPSE-FREE SURVIVAL, DISTANT DISEASE-FREE
SURVIVAL, OVERALL SURVIVAL, CAUSES OF DEATH,
TO ASSESS AND COMPARE HEALTH RELATED QUALITY OF LIFE BETWEEN ARMS
TO CONDUCT A COST-UTILITY ANALYSIS
TRANSLATIONAL RESEARCH
Interim analysis at 5 years
youlia.kirova@curie.fr