56
Participants
Start Date
March 15, 2018
Primary Completion Date
July 21, 2022
Study Completion Date
July 21, 2022
Ribociclib
Ribociclib in addition to endocrine maintenance therapy. Endocrine therapy, at the discretion of the investigator, could have already been started up to 4 weeks before randomization but not later than with first dose of ribociclib.
Anastrozole
1mg once daily as indicated in the SmPC
Letrozole
2,5mg once daily as indicated in the SmPC
Exemestane
25mg once daily as indicated in the SmPC
Fulvestrant
(prefilled syringes with fulvestrant 250mg each), 500mg given once a month, with an additional 500mg dose given two weeks after the first dose as indicated in the SmPC
Studienzentrum Onkologie Ravensburg, Ravensburg
GBG Forschungs GmbH
OTHER