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)

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alain.fourquet@curie.fr