348-349 / 1816
LORD:
Phase III Open Labeled Randomized Non-Inferiority Randomized Clinical Trial
8
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