ESTRO Multidisciplinary Management of Breast Cancer 2017
LORD: Phase III Open Labeled Randomized Non-Inferiority Randomized Clinical Trial
MAIN OBJECTIVE : TO COMPARE THE ACTIVE SURVEILLANCE WITH STANDARD TREATMENT APPROACH (CONVENTIONAL ARM) IN PATIENTS WITH LOW- GRADE DCIS.
PRIMARY END-POINT: IPSILATERAL INVASIVE BREAST CANCER-FREE RATE AT 10 YEARS.
SECONDARY END-POINTS (BOTH TREATMENT ARMS):
♦ TIME TO IPSILATERAL DCIS GRADE II- III
♦ TIME TO CONTRALATERAL DCIS GRADE I-II-III ♦ TIME TO CONTRALATERAL INVASIVE BREAST CANCER ♦ TYPE OF FIRST EVENT FOR PRIMARY ENDPOINT ♦ DISTANT METASTASES AND DEATH DUE TO BREAST CANCER ♦ OVERALL SURVIVAL
♦ TIME TO FAILURE ♦ QUALITY OF LIFE ♦ COST-EFFECTIVENESS
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