ESTRO Multidisciplinary Management of Breast Cancer 2017

ROMANCE:

Phase III Open Labeled Randomized Trial of Omission of Whole-Breast Radiation

Therapy in patients with very low risk DCIS

MAIN OBJECTIVE :

TO DETERMINE WHETHER THE

COMBINED USE OF CLINICAL, MORPHOLOGICAL,

AND IMMUNOHISTOCHEMICAL MARKERS OF LOW

RECURRENCE RISK IN DCIS, COULD BE USED TO

IDENTIFY PATIENTS WHO COULD BE SAFELY

OMITTED THE DELIVERY OF WHOLE-BREAST

IRRADIATION FOLLOWING BREAST-CONSERVING

EXCISION WITH TUMOUR-FREE MARGINS

HYPOTHESES AT 5-YEAR:

< 3,5 % IBR IN EXPERIMENTAL ARM (NO RT)

0,8 % IBR IN REFERENCE ARM (RT)

Α (UNILATERAL) = 2% ; Β = 97%

666 PATIENTS (444 : 222)

alain.fourquet@curie.fr